BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11718512 · Received April 23, 2021

    Report

    Report Number
    1000135560-2021-00033
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 23, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE WAS NOT RETURNED, A PICTURE WAS PROVIDED OF THE DEVICE AFTER THE NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610257 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 3502001 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1