BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3728113 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00271
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    March 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE RECORD WAS NOT COMPLETED FOR THE UNITS RECEIVED. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE UNIT FAILURES BECAUSE THERE WAS NO RECORD OF EVALUATION. THE DHR FOR LOT 01813-02 WAS REVIEWED. THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4). NO SIGNIFICANT TREND OBSERVED.

    Description of Event or Problem · 1

    ONE HANDPIECE FAILED PRIMING, THE OTHER WOULD NOT CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55086 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AOI, INC. 01813-02

    Patients

    Seq Age Sex Outcome Treatment
    1