BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 6355293 · Received February 23, 2017

    Report

    Report Number
    2027111-2017-00440
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    October 17, 2014
    Report Date
    February 23, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    PMA / PMN Number
    20
    Removal / Correction Number
    Z-1621-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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

    LAP CHOLE X3- "ON 8 DIFFERENT CLIP APPLIERS, CLIPS WERE EITHER BEING LOADED INTO THE JAWS SIDEWAYS, OR FALLING OUT OF THE JAWS. ON TWO OCCASIONS A CLIP WOULD FIRE CORRECTLY AND THEN SPIT A CLIP MAKING THE SURGEON HAVE TO SQUEEZE THE HANDLE ONCE IN ORDER FOR THE FOLLOWING CLIP TO "LOAD" PROPERLY. SOME OF THE EVENT SAMPLES WERE THROWN AWAY, SO I'M ONLY SENDING SIX BACK FROM FOUR DIFFERENT LOTS. THE 1223891, 1228544, 1228865X3." TYPE OF INTERVENTION- UNFORMED CLIPS HAD TO BE REMOVED FROM ABDOMEN." TYPE OF INTERVENTION: UNFORMED CLIPS HAD TO BE REMOVED FROM ABDOMEN. PATIENT STATUS - NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135035 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL RESOURCES 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 CA090