BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM- MICROTIP

    MDR report key: 3726607 · Received January 21, 2014

    Report

    Report Number
    2085033-2014-00223
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    January 30, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED DUE TO PATIENT CONTACT; NO OTHER UNIT FROM THIS LOT WAS TESTED FOR STOPPED WORKING ISSUES; THIS LOT HAS (B)(4) FUNCTIONAL COMPLAINTS ((B)(4)- NOT WORKING, (B)(4)- MISCELLANEOUS ISSUES); THE LOT OVERALL HAS A (B)(4) COMPLAINT RATE; THERE IS NO SIGNIFICANT COMPLAINT TREND; DHR'S WERE REVIEWED- THERE IS NO INFO TO SUGGEST THIS LOT WOULD HAVE A HIGHER AMOUNT OF PROBLEMS THAN A LOT WITH A LOW PERCENTAGE.

    Description of Event or Problem · 1

    THE TX1 WAS WORKING FINE DURING THE FIRST 15 SECONDS. THEN STOP WORKING NO SOUND AND THE CONSOLE WAS SHOWING CHECK HAND PIECE. WE CHECK ALL THE CONNECTIONS AND EVERYTHING WAS GOOD. THE DOCTOR TOOK THE TX1 OUT OF THE PATIENT AND WE PRESS THE PEDAL FOR 13 SECONDS AND WAS NOT WORKING. WE CHANGED FOR A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49671 TX1 TISSUE REMOVAL SYSTEM- MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 31112-05

    Patients

    Seq Age Sex Outcome Treatment
    1