BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3030448 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00107
    Date Received
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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.

    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 - "CASE INFORMATION UNKNOWN". PER REP (B)(6) ON (B)(6) 2013 "UNFORTUNATELY, THE OPERATING ROOM DIRECTOR CAN'T REMEMBER WHAT THE PROBLEM WAS EXACTLY. SHE SUSPECTS IT IS THE SAME ISSUE AS THE OTHER CLIP APPLIERS THEY HAVE SENT BACK AND THIS IS THE THEY ARE STICKING WHEN PULLING THE TRIGGER ALL THE WAY BACK." PATIENT STATUS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124807 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1165234

    Patients

    Seq Age Sex Outcome Treatment
    1