BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM ENDO CLIP APPLIER

    MDR report key: 1182771 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03712
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/13/2008. RESULTS: EMPTY AND DEVICE FIRED THROUGH LOCKOUT. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT WAS FIRED THROUGH. WHILE WE WERE UNABLE TO RECREATE THE REPORTED 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. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE DID NOT FIRE THE CLIPS. IT IS UNK HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5MM ENDO CLIP APPLIER NONE FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KL73

    Patients

    Seq Age Sex Outcome Treatment
    1