BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 4809054 · Received June 1, 2015

    Report

    Report Number
    2027111-2015-00341
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 4, 2015
    Report Date
    August 13, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED 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

    CORRECTION - UPDATE LOT# 1240859 UPON PRODUCT RETURNED. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING NOTED THE DEVICE WAS BENT ALONG THE SHAFT. THE CLIPS WERE FIRED OFF ONE AT A TIME AND CONFORMED TO ALL SPECIFICATIONS. ENGINEERING ACTUATED THE DEVICE AND ALL CLIPS LOADED AND CLOSED PROPERLY. THE ROOT CAUSE OF THE CLIPS NOT CLOSING PROPERLY MAY HAVE BEEN CAUSED BY THE CLIP LOADING TECHNIQUE. THE DENT ON THE SHAFT LIKELY HAPPENED WHILE REMOVING THE DEVICE FROM THE TRAY PACKAGING. ALL CLIP APPLIERS UNDERGO 100% VISUAL AND FUNCTIONAL INSPECTION DURING THE MANUFACTURING AND ASSEMBLY PROCESS. AS A PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY INVESTIGATING PACKAGING 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

    LAP CHOLE- "THE CLIP APPLIER WOULD NOT CLOSE ALL THE WAY."PATIENT STATUS: NORMAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351795 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX FZP FZP APPLIED MEDICAL CA500 1222413

    Patients

    Seq Age Sex Outcome Treatment
    1