BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1122037 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01216
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 14, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANTIBACKUP. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ELM5ML DEVICE WAS REC'D IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED 5 CLIPS CONFORMING AND 3 MALFORMED CLIPS DUE TO AN ANTIBACKUP FAILURE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLIPS BECAME MALFORMED, 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 THAT DURING A SIGMOIDECTOMY PROCEDURE, THE CLIP WAS FED TO THE JAW BEFORE THE PREVIOUS CLIP WAS FORMED FULLY FROM THE FIFTH OR SIXTH FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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 FZP ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1