BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3153011 · Received June 8, 2013

    Report

    Report Number
    3005075853-2013-02881
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THERE AN UNUSUAL NOISE FROM THE DEVICE? NO UNUSUAL NOISE FROM THE DEVICE WAS REPORTED FROM THE SURGEON. THE ANALYSIS RESULTS OF THE DEVICE (A) FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. THE JAWS WERE FOUND PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE FOUND CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS OF THE DEVICE (B) FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. THE JAWS WERE FOUND PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE FOUND CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # K90324, EXPIRATION DATE: 12/2017, MANUFACTURING DATE: 01/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIES CHOLECYSTECTOMY PROCEDURE, UPON INITIAL USE OF BOTH OF THE CLIP APPLIERS THE SURGEON SAID THAT THE CLIPS WERE NOT SEATED PROPERLY IN THE JAWS OF THE DEVICE AND WERE "SPITTING" OUT INTO THE PATIENT. THE SURGEON WAS NOT ABLE TO MAKE ANY ATTEMPT TO PLACE ON THE CYSTIC DUCT OR ARTERY DUE TO CLIP NEVER SEATING INTO THE JAWS. THE SURGEON IS FAMILIAR WITH THE PRODUCT AND STATED THAT HE FELT NO INCREASE IN FORCE TO FIRE, A TYPICAL NOISES COMING FROM THE CLIP APPLIER. CASE COMPLETED WITH A THIRD DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254470 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C37F

    Patients

    Seq Age Sex Outcome Treatment
    1