BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3030445 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00102
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 2, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    GALLBLADDER SURGERY: "APPLIER FELL APART IN PATIENTS ABDOMEN. PRODUCT WAS REMOVED WITH NO PATIENT INJURY." PATIENT STATUS: NEW APPLIER WAS USED AND PATIENT WAS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124806 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1182337

    Patients

    Seq Age Sex Outcome Treatment
    1