BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYERS INTERCHANGEABLE VEIN STRIPPER

    MDR report key: 439332 · Received January 17, 2003

    Report

    Report Number
    439332
    Event Type
    Malfunction
    Date Received
    January 17, 2003
    Date of Event
    January 10, 2003
    Report Date
    January 17, 2003
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    GAJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LEFT VEIN STRIPPING DUE TO LEFT GREATER SAPHENOUS VARICOSITY USING A VEIN STRIPPER. DURING THE PROCEDURE THE WIRE & SPRING STRETCHED OUT MAKING THE INSTRUMENT NON-FUNCTIONAL. THE GUIDEWIRE WAS REMOVED AND THE TIP WAS NOTED TO NOT BE INTACT. THE TIP OF THE VEIN STRIPPER WAS MANUALLY EXPRESSED FROM THE VEIN. THE PROCEDURE WAS COMPLETED WITH A 2ND VEIN STRIPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYERS INTERCHANGEABLE VEIN STRIPPER VEIN STRIPPING GUIDEWIRE GAJ ALLEGIANCE HEALTHCARE CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other