BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING FORCEPS

    MDR report key: 3694825 · Received December 13, 2013

    Report

    Report Number
    2183680-2013-00063
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    September 10, 2013
    Report Date
    November 14, 2013
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR DEVICES RETURNED TOGETHER, CANNOT DETERMINE WHICH DEVICE IS BEING REPORTED ON, THEREFORE, ALL 4 DEVICES WILL BE EVALUATED. THE DEVICE WAS RETURNED IN A VERY CLEAN CONDITION. VISUAL INSPECTION REVEALS THE SHAFT IS SLIGHTLY BENT. ALSO FOUND THE INSULATION TO BE SLIGHTLY CRACKED ON ALL 4 ELECTRODES, THE FLARE REMAINS INTACT. THE RATCHET LOCK WAS IN THE "OFF" POSITION. THE JAWS OPEN/CLOSE, BLADE ADVANCES/RETRACTS AND THE LOCK FUNCTIONS AS DESIGNED. THE DEVICE WAS PLUGGED INTO THE LAB GENERATOR SET AT 35 WATTS FOR TESTING. THE DEVICE ACTIVATED AND COAGULATED AS DESIGNED. OBSERVED SLIGHT TISSUE STICKING. DURING ACTIVATION THERE WAS NO SPARKING OBSERVED. CANNOT CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF 4 INSTRUMENTS THAT WERE RETURNED NONE OF THE DEVICES WERE LABELED SO ALL WILL BE EVALUATED AND REPORTED ON FOR THE SAME FAILURE. RELATED MFR REPORT #2183680-2013-00059, 2183680-2013-00061, 2183680-2013-00062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654593 CUTTING FORCEPS CUTTING FORCEPS GEI GYRUS MEDICAL INC. 3006 JF774429

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention