BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2983557 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00946
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DID THE DEVICE FORM THE CLIPS AS INTENDED? NO, IT DIDN'T. IF NOT WHAT WAS THE SHAPE? UNKNOWN. SCISSORED? NO. CLIP GAP? UNKNOWN. TEAR DROP? UNKNOWN. DID THE CLIPS DROP/EJECT FROM THE JAWS? YES, THE SECOND ONE (ACCORDING TO THE SURGEON) DID THE CLIPS FEED INTO THE JAWS? YES. WERE THE CLIPS FORMED PROPERLY AND THEN MOVE OR COME OFF THE TISSUE? THE CLIPS WERE NOT FORMED PROPERLY. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO, NOTHING WAS REPORTED. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO, NOTHING WAS REPORTED. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? THE DEVICE WASN'T FIRED AGAIN AFTER THE INCIDENT. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? LAP CHOLECYSTECTOMY. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? UNKNOWN. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? NO, NOBODY ELSE.

    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, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AFTER FIRING (AT LEAST 3 FIRINGS WERE MENTIONED), THE DEVICE COULD NOT APPLY FIRMLY THE CLIPS OR COULDN'T APPLY THE CLIPS ON THE CYSTIC DUCT TISSUE AT ALL. SOME OF THE CLIPS WERE NOT FIRMLY ATTACHED ON THE TISSUE AND SOME OTHERS JUST FELL WITHOUT HAVING BEEN PREVIOUSLY ATTACHED. THE FIRING TRIGGER WAS NOT BLOCKED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S DEVICE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86319 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CL23

    Patients

    Seq Age Sex Outcome Treatment
    1