BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11739577 · Received April 28, 2021

    Report

    Report Number
    1000135560-2021-00034
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 28, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. THE FRACTURE SITE DID NOT IMMEDIATELY INDICATE A SPECIFIC CAUSE FOR THE FAILURE. TESTING AND DISASSEMBLY OF THE DEVICE DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS.

    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 NEEDLE WAS RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER HAND PIECE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637266 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 NI 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR