BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4916613 · Received July 15, 2015

    Report

    Report Number
    2027111-2015-00445
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 9, 2015
    Report Date
    July 15, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    PMA / PMN Number
    11
    Removal / Correction Number
    Z-1621-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING ACTUATED THE UNIT AND DETERMINED THAT THE UNIT FUNCTIONED PROPERLY. THE CLIPS WERE FIRED OFF ONE AT A TIME AND CONFORMED TO ALL SPECIFICATIONS. ENGINEERING ACTUATED THE UNIT AT DIFFERENT ANGLES ON TUBING TO REPLICATE THE CUSTOMERS' EXPERIENCE OF CLIPS SLIDING OFF TISSUE. THE UNIT WAS DISASSEMBLED FOR FURTHER EVALUATION AND MET ALL SPECIFICATIONS. THE ROOT CAUSE OF THE CLIPS SLIDING OFF THE VESSEL IS UNKNOWN; HOWEVER, CLIP MISALIGNMENT OR CLIP SCISSORING CAN OCCUR ON THICK OR DENSE TISSUE AND WHEN THE CLIP IS APPLIED AT AN ANGLE OTHER THAN PERPENDICULAR TO THE VESSEL. ALL CLIP APPLIERS UNDERGO 100% VISUAL AND FUNCTIONAL INSPECTION DURING THE MANUFACTURING AND ASSEMBLY PROCESS. AS A PART OF THIS PROCESS, EACH UNIT IS INSPECTED FOR CLIP FEEDING AND CLOSURE DURING MANUFACTURING PRIOR TO PACKAGING. 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 THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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.

    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 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

    LAP CHOLE- "CLIPS SLID OFF TISSUE, OPENED A NEW CLIP APPLIER."

    Description of Event or Problem · 1

    "CLIPS SLIDED OFF TISSUE, OPENED A NEW CLIP APPLIER." PATIENT STATUS: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460248 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL RESOURCES 11 1239402

    Patients

    Seq Age Sex Outcome Treatment
    1