BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11838932 · Received May 17, 2021

    Report

    Report Number
    1000135560-2021-00037
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 6, 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
    CT, US
    Reporter Occupation
    NURSE

    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 · 1

    THE DEVICE WAS NOT RETURNED BUT A PICTURE OF THE DEVICE WAS PROVIDED AND REVIEWED.

    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 AND WAS DISLODGED INSIDE THE INCISION. THE NEEDLE PIECE WAS REMOVED WITH A SMALL INSTRUMENT. THE CASE WAS DELAYED APPROXIMATELY 10 MINUTES BUT WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729398 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 0212106 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR