BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3243188 · Received July 19, 2013

    Report

    Report Number
    2027111-2013-00279
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 15, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 CHOLE: "DR (B)(6) 2ND LAP CHOLE OF THE DAY. DR (B)(6) PLACED 4 CLIPS WITH NO PROBLEM. WHEN HE PLACED THE 5TH CLIP, THE TRIGGER ONLY OPENED A 1/4 OF THE WAY. HE MANUALLY PUSHED THE TRIGGER TO THE OPEN POSITION. HE PLACED TWO MORE CLIPS EXPERIENCING THE TRIGGER STICKING AN HAVING MANUALLY OPEN THE TRIGGER. NO MORE CLIPS WERE NEEDED FOR THE CASE." PT STATUS: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338962 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1193438

    Patients

    Seq Age Sex Outcome Treatment
    1