BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3163061 · Received June 11, 2013

    Report

    Report Number
    3005075853-2013-02931
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 17, 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
    NY, 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 AND FED AND FORMED THREE SCISSORED CLIPS, AND THEN THE REMAINING CLIPS WERE FORMED AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, MALFORMED STAPLES INTRO OPERATIVELY. DID NOT FORM COMPLETELY. NO PATIENT INJURY. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263580 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C03N

    Patients

    Seq Age Sex Outcome Treatment
    1