BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1121931 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01201
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RATCHET PAWL. THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT CONFIRMED THAT IT WAS NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND FIRED 7 CLIPS CONFORMING AND 4 MALFORMED CLIPS DUE TO AN ANTI-BACKUP FAILURE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE RATCHET PAWL WAS FOUND DAMAGED CAUSING THE ANTI-BACKUP FAILURE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFORMATION 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE ON THE SECOND FIRING, FOUR CLIPS FELL OUT AND THEN MISFIRED. UNKNOWN IF CLIPS FELL INTO PATIENT AND IF THEY WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1