BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS SEAL OPEN FORCEPS WITH ATTACHED CORD

    MDR report key: 1061706 · Received June 2, 2008

    Report

    Report Number
    1061706
    Event Type
    Malfunction
    Date Received
    June 2, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    GYRUS MEDICAL, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING HYSTERECTOMY WHEN THE GYRUS FORCEP JAWS WOULD NOT STAY CLOSED. THE SURGEON OPTED TO REMOVE THE DEVICE AND REPLACE WITH ANOTHER PAIR WHICH DID FUNCTION APPROPRIATELY. THERE WAS NO INJURY TO THE PATIENT. THE FORCEPS WERE RETAINED BY OR STAFF AND HAVE BEEN SENT TO RISK MANAGEMENT. THE PATIENT'S CASE WAS FINISHED AND SHE WAS SENT TO RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS SEAL OPEN FORCEPS WITH ATTACHED CORD FORCEPS, COAGULATING GEI GYRUS MEDICAL, INC 915000PK 2092004

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR