BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4916627 · Received July 15, 2015

    Report

    Report Number
    2027111-2015-00465
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 15, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FULL UDI# PROVIDED. WE HAVE TRIED TO OBTAIN THE INCIDENT DEVICE FOR EVALUATION WITH NO SUCCESS. NO PRODUCT RETURNED VERIFIED ON SEPTEMBER 30, 2015. 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

    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

    "WE HAD A CLIP APPLIER MALFUNCTION THE OTHER DAY. REF # (B)(4) LOT NUMBER 1229365. THE CLIPS WOULD NOT CRIMP AT THE TOP, WE WERE HEARING THE "POP" SOUNDS PRIOR TO IT EVEN CLOSING. THERE WAS NOT TOO MUCH TISSUE. IT WAS TRIED MULTIPLE TIMES AND STILL WOULD NOT WORK, I HAVE NOTICED THAT IT HAS BEEN MORE DIFFICULT TO CLOSE. I HAVE KEPT THE APPLIER WITH THE PACKAGING AND A CLIP FOR AN EXAMPLE." PATIENT STATUS: "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459620 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1229365

    Patients

    Seq Age Sex Outcome Treatment
    1