BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2875117 · Received December 17, 2012

    Report

    Report Number
    3005075853-2012-05744
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    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 CLIP AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DID THE CLIPS FALL OFF OF THE VESSEL AFTER BEING APPLIED? NO THE SURGEON REMOVED IT WITH A GRASPER EASILY. WERE THE CLIPS FORMED AS INTENDED? NO. SCISSORED?NO. CLIP GAP? NO. DID THE CLIPS FALL INTO THE PATIENT?NO. IF YES, HOW WERE THEY RETRIEVED? WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRING ON ARTERIA CYSTIC AND DUCTUS CHOLEDOCHUS. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? SEE QUESTION BEFORE. 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? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN?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? WHAT WAS FOUND? LAP CHOLECYSTEKTOMIE. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT?NO. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "LAP GALLE" PROCEDURE, THE CLIPS DIDN´T CLOSE COMPLETELY ON THE STRUCTURE. IT WAS EASY TO REMOVE THEM. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1