BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDEVAC

    MDR report key: 2941458 · Received January 24, 2013

    Report

    Report Number
    2941458
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SMALL YELLOW BUTTON ON HANDPIECE CAME LOOSE ON FIELD JUST BEFORE FIRST INCISION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OPERATION:1. RIGHT WIRE LOCALIZED PARTIAL MASTECTOMY.2. RIGHT SENTINEL LYMPH NODE MAPPING.3. BIOPSY OF DEEP RIGHT AXILLARY SENTINEL LYMPH NODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34959 EXTENDEVAC ELECTROSURGICAL PENCIL GEI DEROYAL INDUSTRIES * 29695723

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR