BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1910733 · Received January 31, 2008

    Report

    Report Number
    1527736-2008-00606
    Event Type
    Malfunction
    Date Received
    January 31, 2008
    Date of Event
    December 31, 2007
    Report Date
    January 11, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECIFICATIONS. THE INSTRUMENT LOCKED OUT AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE SCISSORED CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO 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, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1