BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11803458 · Received May 10, 2021

    Report

    Report Number
    1000135560-2021-00036
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 10, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #01. SECTIONS B4, G6, H2, H4 AND H10 HAVE BEEN UPDATED WITH NEW INFORMATION. THE DEVICE LOT NUMBER WAS OBTAINED. THE EXPIRATION DATE, DATE OF MANUFACTURE AND UDI NUMBER WERE UPDATED.

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THE CASE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699210 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 3242001 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1