BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5006367 · Received August 15, 2015

    Report

    Report Number
    2027111-2015-00508
    Event Type
    Malfunction
    Date Received
    August 15, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 22, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST 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

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING FOUND THAT THE JAWS WERE NOT PARALLEL. ENGINEERING WAS ABLE TO REPLICATE YOUR EXPERIENCE OF CLIP SCISSORING. THIS DAMAGE MAY PREVENT THE CLIPS FROM CLOSING COMPLETELY. THE EXACT CAUSE OF THE MISALIGNMENT IS UNKNOWN; HOWEVER, JAW MISALIGNMENT CAN BE CAUSED BY DEVICE ACTUATION ON THICK, DENSE MATERIAL WITH THE JAWS ALIGNED NON-PERPENDICULARLY TO THE APPLICATION PLANE. 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 DURING MANUFACTURING PRIOR TO PACKAGING. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS CONTINUOUS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING MANUFACTURING PROCESS AND INSPECTION ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    "THE CLIP APPLIER IS NOT WORKING BECAUSE THE JAWS CROSS EACH OTHER. CONSEQUENCE THE CLIPS DIDN'T CLOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540712 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1240611

    Patients

    Seq Age Sex Outcome Treatment
    1