BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1024207 · Received March 27, 2008

    Report

    Report Number
    1527736-2008-01930
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 28, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS NOTED TO HAVE THE CAM BROKEN. IN ADDITION, THERE WERE NO CLIPS REMAINING ON THE DEVICE AND THE LOCKOUT WAS NOTED TO HAVE BEEN FIRED THROUGH. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITIONAL, THE APPROPRIATE ENGINEERING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE CAUSE OF THIS ISSUE. 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 AN UNKNOWN PROCEDURE THE CLIP JAMMED AND IT DID NOT COME OUT SMOOTHLY. 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, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1