BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICOUNT SAFETY-SPONGE SYSTEM

    MDR report key: 2025246 · Received March 15, 2011

    Report

    Report Number
    MW5019844
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM INVOLVES THE SURGICOUNT SAFETY-SPONGE COUNTING SYSTEM. THE SYSTEM IS SUPPOSED TO COUNT ONLY BARCODED SPONGES FROM THE COMPANY. HOWEVER, THE DEVICE MISTAKENLY ALSO COUNTS SUTURE PACKS FROM ETHICON AND COUNTS THEM AS OPERATING ROOM TOWELS. THIS ERROR LEADS TO AN INCORRECT SURGICAL COUNT AND HAS THE POTENTIAL FOR SIGNIFICANT PT MORBIDITY AS OPERATING ROOM PERSONNEL PROCEED WITH PROTOCOLS TO ADDRESS INCORRECT SURGICAL SPONGE COUNTS. THE COMPANY WAS CONTACTED AND SAID THEY WERE AWARE OF THE PROBLEM FOR SEVERAL MONTHS, BUT DID NOT YET GET AROUND TO CONTACTING OUR HOSPITAL OR THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICOUNT SAFETY-SPONGE SYSTEM SURGICOUNT LWH SURGICOUNT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1