BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 6019316 · Received October 11, 2016

    Report

    Report Number
    2027111-2016-00677
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    April 11, 2016
    Report Date
    May 2, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915117306
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-1621-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED THE CUSTOMER'S EXPERIENCE OF CLIP MISFIRING. ON MARCH 18, 2016, APPLIED MEDICAL ISSUED A VOLUNTARY CLASS II RECALL OF THE CA090 DIRECT DRIVE CLIP APPLIER DUE TO INCREASED CUSTOMER FEEDBACK INDICATING INCONSISTENT CLIP APPLICATION, WHICH HAS THE POTENTIAL TO LEAD TO UNOCCLUDED VESSELS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS TWO PROCODES. THE INSTRUMENT HAS PROCODE: MDM AND THE CLIPS HAVE PROCODE: FZP. THE INSTRUMENT IS 510(K) EXEMPT AND THE CLIPS 510(K) NUMBER: K011236. THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN: "CLIP CAME OFF JAW AND MISS FIRED." TYPE OF INTERVENTION: "UNKNOWN". PATIENT STATUS: "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670155 CA090, DIRECT DRIVE LCA 3/BX MDM FZP APPLIED MEDICAL RESOURCES CA090 1258614 00607915117306

    Patients

    Seq Age Sex Outcome Treatment
    1