BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUTTING FORECEPS W/ATTACHED CORD

    MDR report key: 1337204 · Received March 3, 2009

    Report

    Report Number
    1337204
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 3, 2009
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE GYRUS WAS PUT INTO THE PATIENT, IT WAS DISCOVERED THAT THE TIP WOULD NOT OPEN. THE TECH THOUGHT THE SILVER INSULATION RING FELL OF IN THE PATIENT. AFTER CHECKING AGAIN THE SECOND TIME, THE TEAM DETERMINED IT HAD NOT FALLEN OFF, BUT ONLY SLIPPED DOWN OVER THE TIP AND THE TIP DID NOT OPEN. INSTRUMENT REMOVED AND NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS CUTTING FORECEPS W/ATTACHED CORD FORECEPS, ESU GEI GYRUS MEDICAL, INC. * 77289AB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR