BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1900685 · Received November 16, 2010

    Report

    Report Number
    3005075853-2010-06558
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    September 28, 2010
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EJECTED CLIPS. 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 FED FOUR CONFORMING CLIPS AND EJECTED THE REMAINING THREE CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND EJECTED CLIPS. 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 A GENERAL PROCEDURE, THERE WERE NO DETAILS ON THE DEVICE FUNCTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE CONSEQUENCES REPORTED. NO DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA D4HW83

    Patients

    Seq Age Sex Outcome Treatment
    1