BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 6358935 · Received February 24, 2017

    Report

    Report Number
    2027111-2017-00740
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    March 7, 2016
    Report Date
    February 24, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915117306
    PMA / PMN Number
    21
    Removal / Correction Number
    Z-1621-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING EVALUATION WAS ASSIGNED AND COMPLETED PRIOR TO JUNE 1, 2016, THEREFORE AN INVESTIGATION SUMMARY IS NOT REQUIRED. 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 AND PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED TO CONDUCT A THOROUGH INVESTIGATION AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS. FDA HAS ISSUED RECALL NUMBER Z-1621-2016 FOR THIS RECALL. THIS REPORT IS BEING FILED AS A RESULT OF A RE-REVIEW OF APPLIED MEDICAL COMPLAINTS RECEIVED BETWEEN JUNE 1, 2014 AND MAY 31, 2016. THIS RETROSPECTIVE REVIEW WAS ASSOCIATED WITH A QUALITY MANAGEMENT SYSTEM (QMS) COMPLIANCE ACTION PLAN DEVELOPED AND PRESENTED TO FDA TO ADDRESS AN APRIL 10, 2015 WARNING LETTER. APPLIED MEDICAL HAS REVISED ITS MDR REPORTING CRITERIA TO BE MORE CONSERVATIVE AND HAS IMPROVED COMPLAINT HANDLING AND MDR REPORTING PROCESSES. THE REVIEWS ENSURED THAT RECENT REPORTABLE EVENTS WERE APPROPRIATELY IDENTIFIED AND REPORTED TO THE DESIGNATED REGULATORY AUTHORITY(IES). THIS REPORT, WHICH REPRESENTS THE INITIAL AND FINAL REPORTS COMBINED, IS BEING SUBMITTED BASED ON THE FINDINGS OF THAT RETROSPECTIVE REVIEW. IN ACCORDANCE WITH 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED 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

    "SURGEON REQUIRED THREE OF PRODUCTS TO BE OPENED. REF CA090, LOT - 1202652 WAS INCLUDED IN KIT WOULD ONLY DISPENSE ONE CLIP REQUIRING SECOND DEVICE TO BE OPENED. REF CA090, LOT - 1214521 PRODUCT TIMES TWO OPENED. CLIPS WERE DISPENSING WITHOUT BEING FIRED. THEY WERE JUST FALLING OUT INTO PATIENT. SURGEON WAS ABLE TO GET ENOUGH CLIPS OUT OF PRODUCT TO COMPLETE CASE BUT WE OPENED THREE DEVICES. I FELT THAT WE SHOULD GET CREDIT FOR TWO." PATIENT STATUS - PATIENT WAS DISCHARGED HOME SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138675 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL RESOURCES 21 1214521 00607915117306

    Patients

    Seq Age Sex Outcome Treatment
    1 2 ADDITIONAL CA090