BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA SMALL APPLIER

    MDR report key: 2901736 · Received January 8, 2013

    Report

    Report Number
    3005075853-2013-00132
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FOURTH OR 5TH. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? LOWER ABDOMINAL WALL. 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? UNK. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD?NO, ASKU. IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? IN. WHAT WERE THE INDICATIONS FOR SURGERY? HERNIA WHAT WAS FOUND? UNK. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. IF SO, WHAT? DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO. IF SO, WHOM?

    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, 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 HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INGUINAL HERNIA AND LYMPH NODE BIOPSY PROCEDURE, THE DEVICE HAD BEEN FIRED FOUR OR FIVE TIMES AND THEN IT BEGAN TO EJECT CLIPS AND NOT FEED PROPERLY. THEY REMOVED THE CLIPS FROM THE PATIENT WITH GRASPERS. THEY DID USE THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9525 LIGACLIP*MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H44V71

    Patients

    Seq Age Sex Outcome Treatment
    1