BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2760778 · Received September 26, 2012

    Report

    Report Number
    3005075853-2012-04386
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 21, 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
    FR
    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, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VISCERAL PROCEDURE, THERE WERE MALFORMED CLIPS. THE CLIPS BENT UPON PLACING AND TORE THE VESSELS. THIS LED TO A HEMORRHAGE WHICH WAS STOPPED BY PLACING NEW CLIPS: THERE WAS NO BLOOD TRANSFUSION. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AM2E

    Patients

    Seq Age Sex Outcome Treatment
    1