BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM-MICROTIP

    MDR report key: 3902859 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00524
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 8, 2014
    Report Date
    February 14, 2014
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE METAL NEEDLE DETACHED FROM THE HANDPIECE AND FELL TO THE FLOOR. A SECOND HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113132 TX1 TISSUE REMOVAL SYSTEM-MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 32213-01

    Patients

    Seq Age Sex Outcome Treatment
    1