BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3727658 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00454
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    November 8, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AOI, INC
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # (B)(4) - 12 VOLT LINE ON POWER SUPPLY UNSTABLE. DOES NOT MAINTAIN SUFFICIENT VOLTAGE CAUSING SCREEN TO REMAIN DARK. REPLACED POWER SUPPLY WITH LOT # 18712-03 (S/N (B)(4)). THE DHR FOR CONSOLE S/N (B)(4) WAS REVIEWED AND SHOWED THAT THE UNIT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THE CONSOLE WAS REPAIRED AND QUALITY CHECKED BEFORE BEING SENT BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    CONSOLE CONTROL SCREEN WOULD NOT LIGHT UP FULLY. POWER WAS IN AND OUT. REQUESTED RETURN FOR CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54851 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR MGI LFL AOI, INC

    Patients

    Seq Age Sex Outcome Treatment
    1