BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM VARICOSE VEIN TREATMENT

    MDR report key: 1860425 · Received October 1, 2010

    Report

    Report Number
    1860425
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 13, 2010
    Report Date
    October 1, 2010
    Manufacturer
    SMITH & NEPHEW, INC.-ENDOSCOPY
    Product Code
    DWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGERY WAS STOPPED 37 MINUTES AFTER INCISION DUE TO A BROKEN PIECE OF EQUIPMENT. THE PIECE IS THE TRIVEX HAND PIECE. THE PLASTIC ACTIVATION SWITCH FELL APART WHEN THE SURGEONS STARTED TO USE IT. THE FAULTY TRIVEX PIECE WAS GIVEN TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIVEX SYSTEM VARICOSE VEIN TREATMENT TRIVEX VEIN TREAMENT SYSTEM HAND PIECE DWQ SMITH & NEPHEW, INC.-ENDOSCOPY NA YQ01435

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR