BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4988756 · Received August 10, 2015

    Report

    Report Number
    2027111-2015-00545
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    April 15, 2015
    Report Date
    August 10, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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. THIS REPORT IS TO FOLLOW UP WITH MEDWATCH REPORT# MW5042179.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE 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.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY- "APPLIED MEDICAL DIRECT DRIVE, DISPOSABLE LAPAROSCOPIC CLIP APPLIER WAS OPENED, NEW, ONTO THE SURGICAL FIELD AND ONLY CONTAINED (1) CLIP. THIS WAS EXCHANGE FOR A "LIKE" DEVICE WHICH HAD THE (20) INDICATED CLIPS. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC CHOLECYSTECTOMY." PATIENT STATUS- "STABLE AT THE COMPLETION OF SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523125 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1240610

    Patients

    Seq Age Sex Outcome Treatment
    1