BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3940669 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05025
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP DIDN'T FORM CORRECTLY, IT SCISSORED UPON FIRING. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418466 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4D72W

    Patients

    Seq Age Sex Outcome Treatment
    1