BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 1623589 · Received February 26, 2010

    Report

    Report Number
    MW5014997
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    February 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A LAPAROSCOPIC TUBAL LIGATION, THE INSTRUMENT, A STRYKER ENDOSCOPY 5MM BIPOLAR FENESTRATED FORCEP, WAS INSERTED INTO THE PATIENT'S ABDOMINAL CAVITY VIA AN OPERATIVE SCOPE USING A SINGLE INCISION SITE. ONCE THE INSTRUMENT WAS OPENED IN THE PATIENT'S ABDOMINAL CAVITY, PLASTIC PORTIONS OF THE INSTRUMENT COVER DISLODGED AND ENTERED THE PATIENT'S ABDOMINAL CAVITY. THE SURGEON THEN MADE A SECOND INCISION AND A SECOND TROCAR WAS INSERTED AND INSTRUMENTATION WAS USED TO REMOVE THE PLASTIC PORTIONS OF THE INSTRUMENT COVER. THE INSTRUMENTS LOT # IS: 0915946, (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY 5MM BIPOLAR FENESTRATED FORCEPS GEI STRYKER ENDOSCOPY 0915946

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability