BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4993935 · Received August 11, 2015

    Report

    Report Number
    2027111-2015-00512
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Removal / Correction Number
    Z-1621-2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FULL UDI UNKNOWN SINCE NO LOT NUMBER WAS 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.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    LAP CHOLE- "DR. (B)(6) HAD A PATIENT HE PERFORMED A LAP CHOLE ON RECENTLY. THE PATIENT HAD POST OP COMPLICATION CONSISTENT WITH A BILE DUCT LEAK. HE PERFORMED AN ERCP AND FOUND THAT EVEN THOUGH THE CYSTIC DUCT HAD 2 10MM CLIPS ON IT, IT WAS LEAKING BILE. INTERVENTION HAD TO BE TAKEN TO STOP THE LEAKING. THE DATE OF INCIDENCE IS NOT AS LISTED ABOVE BECAUSE THE SURGEON DID NOT KNOW THE DATE." INTERVENTION - "THE PATIENT HAD TO GO BACK TO FIX THE BILE DUCT LEAK." PATIENT STATUS - "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523506 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R