BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2823572 · Received November 1, 2012

    Report

    Report Number
    2027111-2012-00332
    Date Received
    November 1, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 1, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    LAP CHOLECYSTECTOMY - "2 CLIPS FIRED AT THE SAME TIME, 2 CLIPS DELIVERED IN THE PT WERE NOT ABLE TO CLOSE THE CLIPS COMPLETELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1170639

    Patients

    Seq Age Sex Outcome Treatment
    1