BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3953896 · Received July 23, 2014

    Report

    Report Number
    2027111-2014-00308
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    October 13, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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: INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING FOUND A DENT IN THE SHAFT OF THE DEVICE NEAR THE KNOB AND CONFIRMED YOUR EXPERIENCE WITH THE DEVICE. THE UNIT WAS DISASSEMBLED FOR FURTHER EVALUATION AND ALL INTERNAL COMPONENTS MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT CONFIRMED THAT THE PRODUCT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. THE ROOT CAUSE IS DUE TO THE BEND IN THE SHAFT OF THE DEVICE, WHICH PREVENTED INTERNAL COMPONENTS FROM MOVING PROPERLY. 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. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    LAP CHOLE- "SURGEON SAID THAT THE 'CLIP TRANSECTS THE VESSEL' WHICH CAUSED BLEEDING AT EVERY POINT OF CONTACT."TYPE OF INTERVENTION: USED CLIP APPLIER FROM DIFFERENT MANUFACTURER.PATIENT STATUS: "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431640 EPIX UNIVERSAL CLIP APPLIER FZP FZP APPLIED MEDICAL CA500 1221170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other