BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727879 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00318
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    June 19, 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

    THE UNIT IS NOT BEING RETURNED FOR EVALUATION. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE ISSUE WITHOUT EVALUATING THE UNIT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 11213-07 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 11213-07. THERE WERE A TOTAL OF (B)(4) REPORTED UNIT FAILURES FROM THIS LOT. THIS LOT HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    DR WAS CUTTING ABOUT 2.5 MINUTES AND THE HANDPIECE JUST STOPPED. TRADED OVER THE OLD HANDPIECE WITH THE NEW. PRIMED AND CONTINUED THE CASE FOR ABOUT 2 MORE MINUTES WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54833 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 11213-07

    Patients

    Seq Age Sex Outcome Treatment
    1