BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3941420 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05040
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 4, 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
    CH
    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 OF THE ER420 DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE FOUND CONDITION. 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 AN UNKNOWN PROCEDURE, THERE WERE UNFORMED CLIPS DEPLOYED AFTER FIRING. CHANGED TO ANOTHER ONE BUT STILL HAD THE SAME ISSUE. CHANGED THE THIRD ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418072 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CX6X

    Patients

    Seq Age Sex Outcome Treatment
    1