BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON MAXI FORCEPS

    MDR report key: 3221851 · Received July 9, 2013

    Report

    Report Number
    2183680-2013-00039
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 21, 2013
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COULD NOT CONFIRM THE CUSTOMERS COMPLAINT OF JAWS NOT OPENING. THE JAWS OF THE DEVICE OPEN AND CLOSE SMOOTHLY NO RESISTANCE FELT. THE SHAFT FULLY ROTATES. JAW WIDTH OR OPENING MEETS SPEC. THE FORCEPS WAS CONNECTED TO GENERATOR, DEVICE ACTIVATED AND COAGULATED AS DESIGNED. VERY SLIGHT STICKING TO THE TISSUE OBSERVED DURING LONG COAGULATION. NO INFO WAS PROVIDED AS TO THE TYPE OF GENERATOR OR SETTING USED DURING THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TUBAL LIGATION PROCEDURE, THE DEVICE JAWS WOULD NOT OPEN WHEN CLAMPED ON TISSUE. THE JAWS WERE STICKING TO TISSUE AS WELL. AN ADDITIONAL TROCAR NEEDED TO BE PLACED TO HELP REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WAS NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313608 ETHICON MAXI FORCEPS MAXI FORCEPS GEI GYRUS MEDICAL INC. 6602-105 JF491103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention