BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1203765 · Received October 10, 2008

    Report

    Report Number
    3005075853-2008-02272
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 20, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/10/2008. JAW. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH THE JAW RAMP BROKEN OFF FROM THE LEFT SIDE. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE RETURNED CONDITION. 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE DEVICE MISFIRED. NO OTHER INFO IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CAUSE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT. ONE DEVICE IS BEING RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1