BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2592980 · Received May 25, 2012

    Report

    Report Number
    3005868511-2012-00002
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 2, 2012
    Manufacturer
    SURGICOUNT MEDICAL, INC.
    Product Code
    GDY
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CANNOT TAKE PLACE AS NEITHER THE DEVICE WAS RETURNED NOR CAN THE EVENT BE REPLICATED. SPONGES ARE FOR GENERAL SURGICAL USE AND NOT EVERY SET OF ENVIRONMENTAL EXPOSURES CAN BE ANTICIPATED. USER WILL BE CAUTIONED IN A CLOSING LETTER NOT TO PLACE DMT LABEL AND RADIOPAQUE X-RAY STRIP IN CLOSE PROXIMITY TO BONE CEMENT DURING ORTHOPEDIC PROCEDURES. THIS IS CONSIDERED TO BE A FINAL REPORT.

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC PROCEDURE (TOTAL HIP CASE), A LAP SPONGE WAS USED TO ABSORB BLOOD AND PRESSURIZE THE BONE CEMENT IMMEDIATELY AFTER IT WAS INJECTED INSIDE THE PROXIMAL FEMORAL CANAL BUT BEFORE IT HARDENED (A COMMON PRACTICE IN TOTAL HIP CASES). THE RADIOPAQUE STRIP ALONG WITH THE DMT LABEL WAS INADVERTENTLY PLACED NEAR THE CEMENT AND THAT THERE WAS NO REQUIREMENT TO DO SO. AS A RESULT, THE DMT LABEL AND RADIOPAQUE STRIP CAME IN CONTACT WITH THE CEMENT AND FRAGMENTS OF THE DMT LABEL AND RADIOPAQUE STRIP BECAME EMBEDDED IN THE CEMENT. SOME OF THE FRAGMENTS WERE REMOVED AND SOME WERE LEFT IN SITU. THE REMAINDER OF THE DMT LABEL AND RADIOPAQUE STRIP WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SPONGE SYSTEM NON-ABSORBABLE GAUZE, INTERNAL (GDY) GDY SURGICOUNT MEDICAL, INC. SM-1818-PB 403876

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE CEMENT (MFR-UNK)