BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2981163 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00885
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 10, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION: DID THE CLIPS FALL INTO THE PATIENT? YES, THE APPLIER CLIPPED THE VESSEL APPROPRIATELY AND WHEN THE HANDLE WAS RELEASED, AS SECOND CLIP FELL INTO THE PATIENT. THIS HAPPENED TWICE. IF YES, HOW WAS THE CLIP RETRIEVED? THE CLIP WAS RETRIEVED USING A ENDO-GRASPER. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? 2ND AND 3RD. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? VESSELS. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? SURGEON INDICATES THAT IT WAS. REP WAS NOT PRESENT. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? SURGEON INDICATES THAT IT WAS NOT. REP WAS NOT PRESENT. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? SURGEON INDICATES THAT IT WAS NOT. REP WAS NOT PRESENT. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO. WHAT WERE THE INDICATIONS FOR SURGERY? NEPHRECTOMY WHAT WAS FOUND? KIDNEY. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? DON'T KNOW. IF SO, WHAT? DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? DON'T KNOW. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THE CLIP APPLIER DISCHARGED TWO CLIPS WITH EVERY SINGLE FIRING. THE FIRING CLIP LIGATED APPROPRIATELY, AND THEN ANOTHER CLIP FELL OUT OF THE DEVICE WITHOUT FIRING THE TRIGGER. THIS HAPPENED SEVERAL TIMES BEFORE THE APPLIER WAS ABANDONED AND ANOTHER DEVICE WAS USED WITHOUT CONSEQUENCE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84266 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CP4C

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO-GRASPER