BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3894074 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04372
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 13, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: MALFORMED CLIP, CLIP JAMMED, EJECTED CLIP. THE ANALYSIS RESULTS OF THE ER420 DEVICE FOUND THAT IT WAS RECEIVED WITH 1 MALFORMED CLIP FED SIDEWAYS AND JAMMED IN THE JAWS. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON TESTING THE DEVICE FOR FUNCTIONALITY, THE JAMMED CLIP WAS REMOVED AND THE DEVICE WAS CYCLED, FED, AND FORMED 3 CONFORMING CLIPS AS INTENDED AND THE REMAINING 10 CLIPS WERE NOT PROPERLY FED INTO THE JAWS, CAUSING THE CLIP TO BE FED SIDEWAYS AND EJECTED; FINALLY, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND FEEDING ISSUE. 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 NEPHRECTOMY PROCEDURE, THE SURGEON CLAIMS THAT THE CLIPS TURNED SIDEWAYS INSIDE OF THE JAWS OF THE APPLIER. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371109 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1