BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3748336 · Received January 24, 2014

    Report

    Report Number
    2085033-2014-00504
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    December 13, 2013
    Report Date
    January 24, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONSOLE GAVE VACUUM TEST ERROR MESSAGE WITH TWO DIFFERENT HANDPIECES. ONE OF THOSE HANDPIECES WAS THEN TESTED ON A DIFFERENT CONSOLE AND IT FUNCTIONED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55577 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1