BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON MAXI FORCEPS

    MDR report key: 2431875 · Received January 3, 2012

    Report

    Report Number
    2183680-2011-00046
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    November 9, 2011
    Report Date
    January 3, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    HTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE DEVICE REVEALED THE JAWS ARE BENT. THE DEVICE WAS RECEIVED WITH THE BI-LUMEN PROTRUDING OVER THE HUMPS OF THE ELECTRODES. THE KYNAR INSULATION IS FRACTURED SEPARATED OFF THE ELECTRODE, WE CANNOT ACCOUNT FOR THE MISSING PIECE OF KYNAR INSULATION, AND IT WAS NOT RETURNED WITH THE DEVICE. THE BREAK IN THE INSULATION MAY HAVE BEEN CAUSED BY THE BI-LUMEN BEING OVER EXTENDED ONTO THE HUMPS OF THE ELECTRODES; THIS ALONG WITH THE BENDING OF THE ELECTRODES MAY HAVE PUT UNDUE STRAIN AT THIS POINT ALONG THE SHAFT OF THE ELECTRODE. DISASSEMBLED THE HANDLE, THE BI-LUMEN IS SECURELY BONDED ONTO THE BOTTOM OF THE SPOOL AS DESIGNED. THE BENDING OF THE JAWS MAY HAVE PUT UNDUE STRAIN ON THE FORCEPS WHICH CAUSED IT TO JAM IN THE CLOSED POSITION REQUIRING EXTRA FORCE TO OPEN THE JAWS. ONCE THE JAWS WERE OPENED THE DEVICE DID OPEN AND CLOSE WITH THE NORMAL AMOUNT OF FORCE. WE CANNOT WITH ANY CERTAINLY DETERMINE THE EXACT CAUSE FOR THE BI-LUMEN COMING OVER THE HUMPS OF THE JAWS CAUSING IT TO STICK IN THE CLOSED POSITION, THE BENDING OF THE JAWS WOULD INDICATE THAT THE DEVICE EXPERIENCED FORCES BEYOND ITS DESIGN INTENT. WE WILL CONTINUE TO MONITOR THE DATA BASE FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LAP ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE SURGEON CONNECTED THE BIPOLAR FORCEPS TO AN OLYMPUS GENERATOR, AND SET THE CUTTING MODE TO 30, COAGULATION MODE 30. HOWEVER, AFTER 10 MINUTES OF SURGERY, WHEN THE SURGEON CLOSED THE JAW, IT COULD NOT BE RE-OPENED AGAIN WITH A SINGLE HAND, THE SURGEON NEEDED TO USE TWO HANDS. IT WAS DISCOVERED THAT THERE WAS A BREAKAGE ON THE PLASTIC PART OF THE JAW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON MAXI FORCEPS FORCEPS HTD GYRUS MEDICAL INC. 6602-105 138939KD

    Patients

    Seq Age Sex Outcome Treatment
    1