BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727706 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00275
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    April 18, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "THE UNIT IS NOT BEING RETURNED FOR EVALUATION. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE WITHOUT EVALUATION THE ALLEGED COMPLAINT PRODUCT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 06513-02 WAS REVIEWED. THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FROM LOT 06513-02. A REVIEW OF LOT HISTORY SHOWED (B)(4) REPORTED UNIT FAILURES FOR FUNCTIONALITY. THIS LOT HAS A FAILURE RATE OF (B)(4). NO SIGNIFICANT TRENDS WERE OBSERVED. PER THE SALES REP, THE CUSTOMER WAS NOT USING A COMPRESSION CUFF, WHICH CAN LOWER THE PSI OF THE BAG. THIS CAUSE CANNOT BE VERIFIED. THE REP ALSO STATED THAT WHEN THE UNITS STOP CUTTING, THE STAFF IMMEDIATELY INSTALLS A NEW CARTRIDGE WITHOUT TRYING TO TROUBLESHOOT THE UNIT."

    Description of Event or Problem · 1

    HAND PIECE STOPPED WORKING SHORTLY AFTER BEGINNING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54325 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI INC. 06513-02

    Patients

    Seq Age Sex Outcome Treatment
    1