BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5005097 · Received August 14, 2015

    Report

    Report Number
    2027111-2015-00509
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 14, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Removal / Correction Number
    Z-1621-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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.

    Additional Manufacturer Narrative · 1

    FULL UDI# PROVIDED. 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. AN INTERNAL CORRECTIVE ACTION REQUEST HAS BEEN INITIATED TO CONDUCT A THOROUGH INVESTIGATION AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS. FDA HAS ISSUED RECALL NUMBER Z-1621-2016 FOR THIS RECALL. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    "WHEN PLACING THE CLIPS, THE CLIPS GET CROSSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540415 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1240611

    Patients

    Seq Age Sex Outcome Treatment
    1