BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3984473 · Received August 6, 2014

    Report

    Report Number
    3005075853-2014-05493
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    May 2, 2013
    Report Date
    June 27, 2014
    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). THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION WITH A CLIP JAMMED BETWEEN THE TOP SHROUD AND THE JAWS. THE CLIP WAS REMOVED IN ORDER TO PERFORM FUNCTIONAL TESTING. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, FED, AND FORMED SEVEN CLIPS AS INTENDED AND IT EJECTED TEN CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459439 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1