BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH FIBRA

    MDR report key: 3161404 · Received June 4, 2013

    Report

    Report Number
    3161404
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL CLAMP INSERTS WERE APPLIED ONTO CLAMP IN USUAL FASHION. CLAMP WAS PLACED ON PORTAL VEIN DURING LIVER TRANSPLANT. WHEN CLAMP WAS REMOVED, SURGEON NOTICED THAT THE SOFT PAD WAS SEPARATING FROM THE PART THAT SEATS ONTO THE CLAMP. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LIVER TRANSPLANT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247163 STEALTH FIBRA SURGICAL CLAMP INSERTS DXC APPLIED MEDICAL RESOURCES CORP * 1178916

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR