BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670123 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00465
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    October 17, 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 Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SALES REP, THE HANDPIECE WAS DISPOSED OF. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFO FOR A COMPLETE INVESTIGATION. THE DHR FOR MICROTIP LOT # 10613-01 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FROM LOT # 10613-01. (B)(4).

    Description of Event or Problem · 1

    HANDPIECE WOULD NOT PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58310 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 10613-01

    Patients

    Seq Age Sex Outcome Treatment
    1