BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ELECTRODE

    MDR report key: 525405 · Received February 11, 2004

    Report

    Report Number
    1418479-2004-00002
    Event Type
    Malfunction
    Date Received
    February 11, 2004
    Date of Event
    January 12, 2004
    Report Date
    January 19, 2004
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A POSTERIOR URETHRAL VALVE SURGERY, THE NEEDLE ELECTRODE BEING USED, REPORTEDLY FLAMED AND A PART OF IT DISINTEGRATED. NO INJURY OCCURRED. THE DAMAGED ELECTRODE WAS THEN DISCARDED BY THE USER FACILITY OR PERSONNEL FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE ELECTRODE NEEDLE ELECTRODE GXZ RICHARD WOLF GMBH 824.03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR