BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3113509 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02339
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 24, 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
    OR, US
    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, RETAINED 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 RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. ANALYSIS (B) BASED ON THE PHOTOGRAPH EVIDENCE THAT THE CLIP FORMATIONS WERE A DIRECT RESULT OF HOW AND WHERE THE DEVICE WAS PLACED, TISSUE POSITION WITHIN THE JAWS, AND POTENTIALLY DEVICE MOVEMENT DURING FIRING AND/OR INCOMPLETE FIRING STROKE. THE CLIP FORMS WERE NOT THE RESULT OF A DEVICE MALFUNCTION, BUT RATHER A USER /APPLICATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPS WOULD NOT FORM. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214228 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C645

    Patients

    Seq Age Sex Outcome Treatment
    1