BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1182741 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03759
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    March 31, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/17/2008. STICKING JAW/CAM. EVAL SUMMARY: THE ANALYSIS RESULTS FOR EL5ML INSTRUMENT FOUND THAT IT WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS RETURNED PARTIALLY CYCLED, WITH THE JAWS CLOSED AND ONE BYPASSED CLIP IN THE JAWS. DUE TO THE RETURNED CONDITION OF THE INSTRUMENT, THE TRIGGER HAD TO BE MANUALLY ASSISTED TO RELEASE THE JAWS. AFTER RELEASING THE JAWS, THE INSTRUMENT FED AND FORMED 14 MALFORMED CLIPS. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE RATCHET PAWL WAS FOUND TO BE WORN OUT CAUSING THE ANTI-BACKUP, IN ADDITION THE FED BAR WAS FOUND DISENGAGED FROM THE FEED BAR CONNECTORS, THEREFORE CAUSING FIRING ISSUES. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CUSTOMER REPORTED THAT THE TRIGGER WAS BROKEN DURING INITIAL USE. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JY10

    Patients

    Seq Age Sex Outcome Treatment
    1