BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4277883 · Received November 25, 2014

    Report

    Report Number
    2027111-2014-00376
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    September 8, 2014
    Report Date
    November 25, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT RESPONDS TO MEDWATCH# (B)(4). INVESTIGATION SUMMARY: TWO (2) EVENT UNITS WERE RETURNED FOR EVALUATION. UPON INSPECTION OF THE FIRST UNIT, ENGINEERING DETERMINED THAT THE UNIT FUNCTIONED PROPERLY. THE CLIPS WERE FIRED OFF ONE AT A TIME AND CONFORMED TO ALL SPECIFICATIONS. THE UNIT WAS DISASSEMBLED FOR FURTHER EVALUATION AND MET ALL SPECIFICATIONS. THE SECOND UNIT WAS EVALUATED AND ACTUATED. THE REMAINING CLIPS WERE FIRED OFF ONE AT A TIME AND CONFORMED TO ALL SPECIFICATIONS. THE UNIT WAS DISASSEMBLED FOR FURTHER EVALUATION AND INTERFERENCE BETWEEN THE JAW AND CLOSURE MEMBER WAS FOUND. ALL CLIP APPLIERS UNDERGO 100% VISUAL AND FUNCTIONAL INSPECTION DURING THE MANUFACTURING AND ASSEMBLY. AS A PART OF THIS PROCESS, EACH UNIT IS INSPECTED FOR CLIP FEEDING DURING MANUFACTURING PRIOR TO PACKAGING. YOUR EXPERIENCE WITH THE SECOND UNIT MAY BE DUE TO THE FRICTION BETWEEN THE CLOSURE MEMBER AND JAW, WHICH CAN CAUSE THE JAWS TO RETRACT SLOWLY AND MISFIRE CLIPS. APPLIED MEDICAL HAS RECENTLY IMPLEMENTED DEVICE ENHANCEMENTS INTENDED TO MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. ALL PRODUCT SHIPPED NOW CONTAINS THESE IMPROVEMENTS. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS DOCUMENT REPRESENTS OUR INITIAL/FINAL REPORT.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY- "THE CLIP WAS NOT HOLDING OR DEPLOYING PROPERLY, LOT#1221467, DR. SHINDLE."PER MEDWATCH REPORT:THE CLIP WAS NOT HOLDING OR DEPLOYING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765488 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1221468

    Patients

    Seq Age Sex Outcome Treatment
    1