BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE INC.

    MDR report key: 455528 · Received April 22, 2003

    Report

    Report Number
    455528
    Event Type
    Malfunction
    Date Received
    April 22, 2003
    Date of Event
    April 9, 2003
    Report Date
    April 18, 2003
    Manufacturer
    ARTHROCARE INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY USING THE ARTHROCARE WAND TURBO VAC 90 3.5MM 90 SEG. SUCTION, 2 MICROSCOPIC PIECES FROM WAND CAME LOOSE AND WERE NOT ABLE TO BE RETRIEVED. PHYSICIAN TO FOLLOW PATIENT FOR ANY ADVERSE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE INC. TURBO VAC WAND HRX ARTHROCARE INC. AS 1335-01 3601332-2

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other