BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 1781482 · Received July 29, 2010

    Report

    Report Number
    3004028675-2010-00004
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 28, 2010
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K090159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSORB SUBCUTICULAR STAPLER HAS BEEN USED TO CLOSE KNEE INCISIONS WITHOUT INCIDENT. THERE IS NO DEFINITIVE ETIOLOGY TO WOUND SEPARATION AT 30 DAYS POST-OP. THE PT RETURNED TO SURGERY FOR A REMEDIAL PROCEDURE ON THE UPPER 25% OF THE INCISION.

    Description of Event or Problem · 1

    FOLLOWING KNEE REPLACEMENT SURGERY, A FEMALE PT EXPERIENCED A PARTIAL WOUND SEPARATION AT 30 DAYS POST-OP REQUIRING A SUBSEQUENT REMEDIAL PROCEDURE UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SUBCUTICULAR STAPLER GDW - STAPLE, IMPLANTABLE GDW INCISIVE SURGICAL 2030 100601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention