BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902905 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00538
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 14, 2014
    Manufacturer
    TENEX HEALTH
    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

    Description of Event or Problem · 1

    THE ATTACHMENT TUBE OF SALINE TO THE HANDPIECE WAS BROKEN AND NOTICED WHILE PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113557 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRSONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 34513-04

    Patients

    Seq Age Sex Outcome Treatment
    1