BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727992 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00254
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    March 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

    THE UNIT WILL NOT BE RETURNED FOR EVALUATION. IT IS NOT POSSIBLE TO DETERMINE THE ASSIGNABLE CAUSE OF THE ISSUE. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. A REVIEW OF THE DHR FOR LOT 32112-03 WAS REVIEWED. THE PART MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FOR LOT 32112-03. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE (B)(4) UNITS THAT FAILED FOR FUNCTIONALITY. THIS LOT HAS A FAILURE RATE OF (B)(4). NO SIGNIFICANT TRENDS WERE OBSERVED.

    Description of Event or Problem · 1

    AFTER 48 SECONDS THE HANDPIECE STOPPED WORKING. A SECOND MICROTIP WAS USED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55135 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AOI, INC. 32112-03

    Patients

    Seq Age Sex Outcome Treatment
    1