BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2194603 · Received July 14, 2011

    Report

    Report Number
    3005868511-2011-00001
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    LWH
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE 2008, USERS AND SURGICOUNT MEDICAL HAVE BECOME AWARE OF 4 INSTANCES OF THIS SPECIFIC DEVICE PROBLEM AND MDRS WERE FILED ON EACH OCCASION. SURGICOUNT WILL PROVIDE A FOLLOW-UP REPORT SUMMARIZING STATUS OF INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    AT THE END OF A SURGICAL PROCEDURE, A SURGICOUNT LAPAROTOMY SPONGE LABELED WITH A DATA MATRIX CODE COULD NOT BE SCANNED AND COUNTED AS INTENDED. IT WAS VISUALLY DETERMINED THAT THE LABEL WAS DAMAGED. SINCE THE SPONGE IS NOT SCANNED UNTIL THE END OF THE SURGICAL PROCEDURE, THE CONCERN WAS THAT IT IS NOT KNOWN IF THE DAMAGE HAD OCCURRED PRIOR TO USE OF THE PROCEDURE KIT CONTAINING THE SPONGE OR DURING THE SURGICAL PROCEDURE ITSELF. THE LABEL SURFACE AREA IS 0.5 SQ IN. AND FROM A PICTURE OF THE USED SPONGE IT APPEARS THAT APPROX 15-20% OF THE LABEL SURFACE IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SPONGE SYSTEM NON ABSORBABLE SURGICAL SPONGE LWH SURGICOUNT MEDICAL SM-1818-PB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK