BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1080351 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00368
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 16, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MALFORMED CLIP. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED 5 CLIP CONFORMING AND 1 MALFORMED CLIP DUE TO BYPASS ISSUES. 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 HISTORY REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE THE CLIP WAS NOT FED INTO THE JAWS PROPERLY AND IT COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE FZP ETHICON ENDO-SURGERY, LLC NA E4KT77

    Patients

    Seq Age Sex Outcome Treatment
    1