BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25CM PKS SEAL, OPEN FORCEPS, CURVED JAW

    MDR report key: 1362377 · Received March 26, 2009

    Report

    Report Number
    2183680-2009-00019
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    February 24, 2009
    Report Date
    March 26, 2009
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K024286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FORCEPS WERE RECEIVED WITH THE SHIM DETACHED FROM THE BOTTOM ARM. THERE IS EVIDENCE OF ADHESION ON THE BOTTOM OF THE SHIM INSULATOR WITH VERY LITTLE ADHESIVE RESIDUE ON THE ARM OF THE FORCEPS. NO ADHESIVE WITHIN THE HOLES ON THE ARM. THE OTHER SHIM WAS REMOVED FOR COMPARISON, AND ADHESIVE RESIDUE WAS FOUND ON THE ARM OF THE FORCEPS AND WITHIN THE POST HOLES. BOND FAILURE BETWEEN THE SHIM AND THE FORCEPS ARM.

    Description of Event or Problem · 1

    DURING A TOTAL VAGINAL HYSTERECTOMY, THE SURGEON NOTICED THAT THE SHIM WAS MISSING FROM THE OPEN FORCEPS AT THE END OF THE PROCEDURE. THE SHIM WAS LOCATED INSIDE THE PATIENT AND WAS RECOVERED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 25CM PKS SEAL, OPEN FORCEPS, CURVED JAW PKS SEAL, OPEN FORCEPS, CURVED JAW 25CM GEI GYRUS MEDICAL INC. 3103PK 8262118

    Patients

    Seq Age Sex Outcome Treatment
    1