BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3050849 · Received April 10, 2013

    Report

    Report Number
    3005075853-2013-01706
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 18, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DID THE CLIPS NOT FORM COMPLETELY OR DID THE FORMED CLIPS NOT SECURE THE VESSEL? CLIP DID NOT FORM PROPERLY, AS STATED THE DISTAL END CLOSED BUT THE PROXIMAL REMAINED OPEN. DID IT HOLD ON THE VESSEL? NO. IF NO, DID THE CLIP FALL INTO THE PATIENT? UNKNOWN. IF YES, HOW WAS IT RETRIEVED? UNKNOWN. WAS THE CLIP FORMED AS INTENDED? NO, THE CLIP DID NOT CLOSE AT THE PROXIMAL END. WAS THERE BLEEDING? UNKNOWN. WAS THERE LEAKAGE? UNKNOWN. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? UNKNOWN. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? UNKNOWN. 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? UNKNOWN. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNKNOWN. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNKNOWN. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? STANDARD LAP CHOLE. 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? UNKNOWN. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, CLIPS DEPLOYED, CLOSED DISTALLY BUT DID NOT CLOSE FULLY PROXIMALLY, MEANING IT DID NOT CLIP THE VESSEL SECURELY. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148295 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1