BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3080614 · Received April 26, 2013

    Report

    Report Number
    3005075853-2013-01989
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DID CLIP FALL INTO THE PATIENT? NO. IF YES, HOW WAS IT RETRIEVED? NOT APPLICABLE. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? AS NOTED THE INITIAL 5-6 FIRINGS. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC DUCT AND CYSTIC ARTERY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? UNKNOWN. 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? NO. 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? REMOVAL OF GALLBLADDER NO OTHER INFORMATION PROVIDED. THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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, WHEN THE SURGEON FIRED THE DEVICE ONTO THE VESSELS, THE CLIPS WERE NOT FORMING CORRECTLY. IT IS ALLEGED THAT THE CLIPS FORMED LOOSELY FOR THE INITIAL 5-6 FIRINGS AND THEN BEGAN TO FUNCTION CORRECTLY. THE SURGEON HAD TO REMOVE THE LOOSE CLIPS AFTER EVERY ALLEGED MISFIRE. SAME DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181335 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CL23

    Patients

    Seq Age Sex Outcome Treatment
    1