BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3221042 · Received July 11, 2013

    Report

    Report Number
    3005075853-2013-03518
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 9, 2013
    Report Date
    July 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS ARE FIRED, SHOOTING OUT OF THE JAWS OF THE CLIP APPLIER IMMEDIATELY AFTER LOADED IN THE JAWS. ANOTHER DEVICE WAS OPENED, THIS FUNCTIONED WELL. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320567 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H44D7W

    Patients

    Seq Age Sex Outcome Treatment
    1