BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3162133 · Received June 11, 2013

    Report

    Report Number
    3005075853-2013-02923
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: DID THE CLIP FALL OFF THE VESSEL AND INTO THE PATIENT? NO. IF SO HOW WAS THE CLIP RETRIEVED? N/A. AT WHAT FIRING DID THIS OCCUR? APPROX 2ND OR 3RD FIRING. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE WHEN FIRING THE DEVICE? NO. WAS THE DEVICE FIRED ACROSS ANY HARD OBJECTS DAMAGING THE JAWS OF THE DEVICE? NO. 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 REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THE CLIP APPLIER WAS LOADING THE CLIP SLOWLY INTO THE JAWS AND DID NOT FEEL LIKE THE CLIP WAS CLOSING DOWN ON THE VESSEL WHEN FIRING. THE NEXT CLIP THAT WAS DEPLOYED WAS ALSO TAKING A LONG TIME TO DEPLOY. THE JAWS OF THE CLIP APPLIER WERE LOOSE AND GAVE THE APPEARANCE THAT THERE IS A SPRING BROKEN INSIDE. CASE COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262314 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1