BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS LYONS DISSECTING FORCEPS W/ATTACHED CORD

    MDR report key: 1161743 · Received September 10, 2008

    Report

    Report Number
    1161743
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 10, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER COAGULATING THE UTERINE VESSELS, THE PK DEVICE BARREL AND GRASPER MALFUNCTIONED AND ONE OF THE JAWS BECAME DETACHED. THE JAWS WERE RETRIEVED FROM THE PATIENT'S ABDOMEN.====================== MANUFACTURER RESPONSE FOR DISSECTING FORCEPS W/ATTACHED CORD, PKS LYONS DISSECTING FORCEPS W/ATTACHED CORD======================HAVE NOT RECEIVED A RESPONSE BACK AS OF THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS LYONS DISSECTING FORCEPS W/ATTACHED CORD HANDPIECE, ESU, CUTTING FORCEPS GEI GYRUS MEDICAL, INC. * 8192084(2), 8157060(2)

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR