BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11845441 · Received May 18, 2021

    Report

    Report Number
    1000135560-2021-00038
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 21, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006215
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. DUE TO THE STATE IN WHICH THE DEVICE WAS RECEIVED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE FRACTURE SITE DID NOT IMMEDIATELY INDICATE A SPECIFIC CAUSE FOR THE FAILURE. DISASSEMBLY OF THE DEVICE DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #02. SECTIONS B4, B5, G6, H2 , H6 AND H10 HAVE BEEN UPDATED WITH NEW OR CORRECTED INFORMATION. THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE PLASTIC CASE NOSE OF THE HANDPIECE HAD BEEN PARTIALLY MELTED AND DAMAGED. DUE TO THE STATE IN WHICH THE DEVICE WAS RECEIVED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE DAMAGE DID NOT IMMEDIATELY INDICATE A SPECIFIC CAUSE FOR THE FAILURE. DISASSEMBLY OF THE DEVICE DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS. (NOTE: IT WAS INITIALLY REPORTED THAT THE MICROTIP NEEDLE HAD BROKEN, BUT IT WAS LATER CONFIRMED TO BE THE PLASTIC CASE ONLY).

    Description of Event or Problem · 0

    A PORTION OF THE OUTER PLASTIC CASE (CASE NOSE) ON THE TX MICROTIP HANDPIECE WAS DAMAGED AND PARTIALLY MELTED DURING A PROCEDURE. (NOTE: IT WAS INITIALLY REPORTED THAT THE MICROTIP NEEDLE HAD BROKEN, BUT IT WAS LATER CONFIRMED TO BE THE PLASTIC CASE ONLY.) THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    AT THE BEGINNING OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737641 TX1 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-1003-001 2612001 00857156006215

    Patients

    Seq Age Sex Outcome Treatment
    1