SurgiCount+ System
by Stryker Instruments
· Based in United States →
— Intelligent surgical sponge counting and blood loss assessment for enhanced patient safety.
Contact vendor for pricing
Regulatory Status Disclosed
Overview
The SurgiCount+ Safety-Sponge System by Stryker Instruments is a digital sponge management and blood loss assessment platform designed for the operating room (OR) and labor and delivery care settings. It is utilized by surgical teams, obstetricians, and perioperative nursing staff to standardize clinical protocols and reduce manual errors.
The system integrates ultra-high radio frequency identification (UHF-RFID) technology embedded directly into surgical sponges. This allows clinicians to uniquely identify, track, and locate individual sponges within the sterile field using a wireless Bluetooth-enabled reader, eliminating duplicate or false-correct counts.
Key capabilities and workflow integrations include:
- Triton AI Integration: Incorporates Triton technology to assess real-time cumulative blood loss (QBL) across the continuum of care, helping clinicians differentiate blood from other surgical fluids.
- EMR Integration: Connects directly with hospital electronic medical records to seamlessly track and document patient information.
- Universal Reporting Tool (URT): Features an analytics dashboard that provides visibility into hospital-wide trends to drive standardization and quality improvement.
- Hardware Interface: Utilizes an intuitive, user-friendly tablet interface mounted on a dedicated workstation stand to streamline the setup and turnover process.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- UHF-RFID tagged sponges for unique identification and accurate counting
- Wireless reader for scanning, counting, and locating sponges in the OR
- Intuitive, user-friendly tablet interface for streamlined operation
- EMR connectivity and digital platform for documented proof and data transfer
- Workstation stand with sponge hanging bags and sterile reader covers for maneuverability
- Integrated Triton AI technology for quantitative blood loss (QBL) assessment
- Ability to differentiate blood from other fluids using AI (Triton AI)
- Bluetooth scale for batch weighing blood-soaked items (Triton)
- Universal Reporting Tool (URT) analytics dashboard for hospital-wide trends
- Real-time cumulative blood loss assessment across the continuum of care
Use Cases
- Preventing retained surgical sponges in the operating room
- Accurate, real-time blood loss assessment during surgical procedures
- Standardizing clinical protocols for charting and sponge management
- Reducing manual data entry errors and improving data accuracy
- Digitizing and enhancing hemorrhage response protocols
- Improving overall patient safety and outcomes in surgical environments
What Physicians Need to Know
Intraoperative Guidance
The SurgiCount+ System utilizes UHF-RFID tagged sponges for unique identification, effectively eliminating false-correct, duplicate, or unknown counts. A wireless reader is used to scan, count, track, and locate surgical sponges within the operating room and sterile fields in real-time. It provides real-time verification of manual sponge counts and offers a digital ledger for continuous reconciliations throughout the surgical procedure. The system is integrated with Stryker's Triton technology, which incorporates AI to differentiate blood from other fluids, enabling real-time cumulative blood loss assessment. Triton QBL further integrates hospital-specific protocols and text alerts to aid in coordinating the clinical team's hemorrhage response.
Post-Operative Monitoring
SurgiCount+ provides accurate, fully compliant post-operative documentation through SurgiCount360, offering individual procedure reports and aggregate data for auditable evidence. Its wound-pack reconciliation feature records the time, type, and ID of retained sponges, communicates this data across connected tablets, triggers email notifications, and updates packed sponge counts during recovery or subsequent procedures. A final reconciliation is transmitted and logged to a secure cloud database, creating a permanent record of complete sponge removal.
Operating Room Workflow Integration
The system is designed to simplify and streamline OR workflows, significantly reducing the time spent searching for missing sponges. It features an intuitive, user-friendly tablet interface and seamlessly integrates with existing manual sponge counting protocols. SurgiCount+ enables real-time Electronic Medical Record (EMR) connectivity, providing documented proof and helping to reduce manual data entry errors. It aggregates case data and facilitates seamless tracking and communication of patient information. The system includes a mobile workstation stand equipped with sponge hanging bags and sterile reader covers, designed for easy maneuverability and minimal floor space.
Physician Tip
Leverage SurgiCount+ to enhance patient safety by minimizing the risk of retained surgical sponges and to gain real-time, accurate blood loss assessment, which can critically inform intraoperative decision-making, particularly in hemorrhage management. The streamlined workflow and robust documentation can also contribute to a more efficient and less stressful operating room environment for the entire surgical team.
SurgiCount+ integrates UHF-RFID technology for unique sponge identification and tracking. It offers real-time connectivity with hospital Electronic Medical Records (EMR) for seamless data transfer and documentation. A key integration is with Stryker's Triton technology, which uses AI for quantitative blood loss assessment by differentiating blood from other fluids.
Details
| Category | Surgical AI |
| Pricing | Contact vendor for pricing — Enterprise-level solution; custom quotes based on facility needs and integration requirements. |
| Deployment | Hybrid (on-premise hardware with EMR integration and cloud-based server/storage) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The SurgiCount+ System Software (K232250, cleared 01/11/2024) is a multifunctional software application intended as an adjunct for estimating blood loss and managing surgical sponges and other absorbent items, incorporating Triton AI, SC+ Sponge Counting, and Triton QBL configurations. |
| Integrations | |
| EHR | Not specified |
| Specialties | Anesthesiology, General Surgery |
What the Web Says
The SurgiCount+ System by Stryker is generally well-received for its ability to enhance patient safety and operational efficiency in surgical settings by accurately counting sponges and instruments. Reviewers highlight its effectiveness in reducing the risk of retained surgical items and improving workflow, though some note the initial investment and potential for user error as considerations.
Overall: PositiveStrengths
- Significantly reduces the risk of retained surgical items (RSIs)
- Improves patient safety outcomes
- Enhances operational efficiency in the OR
- Provides accurate and reliable counting of sponges and instruments
- Streamlines the counting process, saving time
- Reduces manual counting errors
Limitations
- High initial investment cost
- Requires staff training for effective use
- Can be perceived as an additional step in the workflow by some
- Potential for user error if not properly implemented or followed
- Integration challenges with existing hospital IT systems in some cases
- Reliance on technology may lead to complacency in manual checks
Based on reviews from: Stryker.com (product information), Healthcare IT News, Physician forums and medical journals, Reddit (healthcare professional subreddits), G2 (general tech reviews, though specific SurgiCount+ reviews are limited), Capterra (general tech reviews, though specific SurgiCount+ reviews are limited)
Last updated: 2026-07-19
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Press & Coverage
X-ray Interpreter
SurgiCount+ System | FDA Radiology AI Device - X-ray Interpreter
The SurgiCount+ System by Stryker Instruments is a multifunctional software that has received FDA approval as a radiology AI device. It contributes to news, research, and regulatory approvals in the field of artificial intelligence in healthcare.
2024-01
ODT Magazine
Digital Domination: ODT's 2024 Year in Review - ODT Magazine
Stryker Corp. received FDA clearance for its AI-enabled SurgiCount+ System, a software application designed for estimating blood loss and managing surgical sponges. This was highlighted in ODT's 2024 Year in Review as a significant AI-based approval in the orthopedic industry.
2024-11
Mordor Intelligence
Plastic Surgery Instruments Market Size, Forecast, Share & Report Analysis 2031
In November 2024, Stryker introduced the next-generation SurgiCount+ with AI-powered blood-loss analytics and wireless sponge tracking, offering quantifiable workflow savings in plastic surgery. The report also notes that AI-integrated consoles like SurgiCount+ provide real-time blood-loss analytics for surgical quality monitoring.
2026-01
accessdata.fda.gov
March 16, 2026 Stryker Instruments Michael Mazelin Senior Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan - accessdata.fda.gov
A 510(k) summary from March 2026 details that the SurgiCount+ System Software is a multi-functional application for estimating blood loss and managing surgical sponges, incorporating Triton AI, SC+ Sponge Counting, and Triton QBL configurations. The document concludes that the SurgiCount+ System is as safe and effective as its predicate device.
2026-03
The Motley Fool
Stryker - SYK - Stock Price & News | The Motley Fool
Stryker launched new products in 2024, including the SurgiCount+ system, as part of its growth and expansion strategy. The company's digital health and AI initiatives include virtual care platforms and clinical communication tools.
2024
FDA.report
January 11, 2024 Stryker Instruments Ms. Patti Arndt Principal Specialist, Regulatory Affairs 1941 Stryker Way Portage, Michigan - FDA.report
The FDA's 510(k) summary for the SurgiCount+ System, dated January 11, 2024, describes it as a multifunctional software application for estimating blood loss and managing surgical sponges and other absorbent items. The system includes Triton AI, SC+ Sponge Counting, and Triton QBL configurations.
2024-01
Oxford Academic
Growth in FDA-Approved Artificial Intelligence Devices in Plastic Surgery: A Key Look Into the Future - Oxford Academic
A peer-reviewed article from October 2024 highlights the SurgiCount+ System (Stryker Instruments) as an FDA-approved AI/ML-based device in plastic surgery. Approved on January 11, 2024, it uses RFID-tagged sponges and enhanced software for accurate counting, locating, and estimating hemoglobin mass to manage surgical sponges and blood loss.
2024-10
FDA
Artificial Intelligence-Enabled Medical Devices - FDA
The FDA's list of Artificial Intelligence-Enabled Medical Devices includes the SurgiCount+ System by Stryker Instruments, categorized under General Hospital with product code PBZ. This entry was updated on March 16, 2026.
2026-03
Videos
Product demos, reviews, and walkthroughs for SurgiCount+ System.
SurgiCount+Safety Sponge System
Salina Regional Health Center
Frequently Asked Questions
The AI in SurgiCount+, often integrated with technologies like RFID, enhances accuracy by providing real-time tracking and identification of surgical sponges, aiming to reduce human error and eliminate false counts. However, limitations can include challenges with obscured sponges, potential for false positives or negatives, and the need for human verification in complex scenarios.
SurgiCount+ primarily collects operational data related to sponge counts and procedural timelines, rather than direct patient health information. The system is designed with robust encryption and access controls to protect any indirectly associated data, ensuring strict adherence to HIPAA and other relevant privacy standards.
SurgiCount+ is designed for seamless integration with major EHR and OR management systems through standard APIs, allowing for automated documentation of sponge counts and streamlined workflows. Technical requirements typically involve network connectivity and specific software configurations, which are assessed during implementation to ensure compatibility and data flow.
Yes, the AI components of SurgiCount+ undergo rigorous validation processes and typically receive necessary regulatory clearances, such as FDA approval, for medical device use. This involves extensive testing in simulated and real clinical environments to demonstrate its safety and efficacy in preventing retained surgical items.
Implementation costs for SurgiCount+ include hardware, software licenses, and integration services, with ongoing maintenance fees. While potentially higher upfront than manual methods, its value proposition lies in significantly reducing the risk of retained surgical items, which can lead to substantial cost savings from adverse events and improved patient safety outcomes.
While SurgiCount+ aims to minimize errors, institutions should understand that ultimate responsibility for patient safety remains with the surgical team. Hospitals should review their agreements with the manufacturer and ensure proper protocols for human oversight and verification are in place to mitigate liability, as case law on AI-related medical errors is still evolving.
SurgiCount+ differentiates itself by leveraging advanced AI, often in conjunction with RFID technology, for real-time visual verification and tracking of sponges. This integrated AI approach aims for higher accuracy and fewer false positives/negatives compared to systems relying solely on passive RFID or manual counts, and can also integrate blood loss assessment.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19