BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3030438 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00111
    Date Received
    March 26, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    LAP CHOLE - "CLIPS FELL OFF, SCISSORED, DID NOT FORM COMPLETELY." PATIENT STATUS: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123314 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1188028

    Patients

    Seq Age Sex Outcome Treatment
    1 YES COMPETITIVE