BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3963138 · Received July 29, 2014

    Report

    Report Number
    3005075853-2014-05305
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 18, 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 Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. 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 FIVE CLIPS AS INTENDED AND IT EJECTED FIVE CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. 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 NEPHRECTOMY PROCEDURE THE DEVICE DIDN'T LOAD PROPERLY THE CLIPS. THE CLIPS WERE LOADED SIDEWAYS AND SUBSEQUENTLY EJECTED. THE CLIPS WERE MALFORMED. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441385 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1