BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 917871 · Received September 18, 2007

    Report

    Report Number
    MW5003842
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 7, 2007
    Report Date
    September 18, 2007
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PUTTING IN TROCAR -VISIPORT- DURING LAPAROSCOPIC, PHYSICIAN WAS UNABLE TO VISUALIZE INTO SKIN LAYER. HE REMOVED SCOPE AND TROCAR AND NOTICED THE LENS WAS OFF THE SCOPE AND 6 PIECES FROM INSIDE THE SCOPE WERE INSIDE THE TROCAR. TROCAR AND SCOPE WERE TAKEN OFF THE FIELD. TROCAR PENETRATED INTO FASCIA LAYER ONLY. STRYKER REP ADVISED THAT THE AGE OF THE INSTRUMENT AND THE USE OF NON-RECOMMENDED AUTOCLAVE STERILIZATION MAY HAVE CONTRIBUTED TO THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY VISIPORT KOG STRYKER ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 YR