BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1850352 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05633
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED BEEPING TONES. THIS CRT-D WAS INTERROGATED, BUT NO IRREGULARITIES OR FAULT CODES WERE OBSERVED. THE PHYSICIAN ELECTED TO LEAVE THIS CRT-D IMPLANTED. IT WAS NOTED THE IMPLANT WAS DONE IN A LABORATORY WITH A STEREOTAXIS NIOBE NAVIGATION SYSTEM, WHICH GENERATED A HIGH MAGNETIC FIELD. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY TWO HOURS AFTER THE IMPLANT PROCEDURE. THE ATTENDING PHYSICIAN DISCUSSED THAT THE DEATH WAS NOT RELATED TO THE DEVICE. THE CAUSE OF DEATH WAS A PLEURAL HEMORRHAGE. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TIP OF THE CLIP WAS CLOSED A LITTLE AND FED INTO THE JAW FROM THE SECOND FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1