BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3944051 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05079
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 16, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE ER420 DEVICE FOUND THAT IT WAS RECEIVED WITH A MALFORMED CLIP JAMMED IN JAWS FED SIDEWAYS. THE JAWS WERE FOUND PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON REMOVAL OF JAMMED CLIP THE DEVICE WAS FIRED AND 14 CONFORMING CLIPS WERE FORMED AND THE REMAINING 3 CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED 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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE DID NOT FIRE AT THE FIRST FIRING. A SECOND DEVICE WAS PULLED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422783 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CN64

    Patients

    Seq Age Sex Outcome Treatment
    1