BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROWAND

    MDR report key: 1033730 · Received April 9, 2008

    Report

    Report Number
    1033730
    Event Type
    Malfunction
    Date Received
    April 9, 2008
    Date of Event
    January 28, 2008
    Report Date
    April 9, 2008
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPIC LEFT SHOULDER SURGERY, THE DOCTOR NOTICED SMOKE COMING FROM THE CAUTERY WAND; WHERE THE CABLE MEETS THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROWAND HANDPIECE, ESU, ORTHOPEDIC GEI ARTHROCARE CORPORATION * 4532670-A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR