BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TXB TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 10399800 · Received August 12, 2020

    Report

    Report Number
    1000135560-2018-00037
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 9, 2020
    Report Date
    August 12, 2020
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006093
    PMA / PMN Number
    K181367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A PATIENT DEVELOPED A WOUND BREAKDOWN, WITH DELAYED HEALING, THREE WEEKS AFTER A PROCEDURE WITH THE TX SYSTEM. IT APPEARED TO BE A POST-PROCEDURE INFECTION. THE EXACT CAUSE OF THE BREAKDOWN IS UNCLEAR. THE PATIENT'S HEALING ABILITY AND CIRCULATION IN THE LEG MAY HAVE BEEN COMPROMISED. NO PATIENT INJURY OR COMPLICATIONS WERE EVIDENT IMMEDIATELY AFTER THE PROCEDURE OR AT THE ONE-WEEK FOLLOW-UP. SOME REDDENING OF THE SKIN WAS SEEN AT TWO WEEKS. BUT, OVERHEATING OF THE MICROTIP DURING THE PROCEDURE MAY HAVE POTENTIALLY CONTRIBUTED TO THE CONDITION. HOWEVER, THE EXTENT OF THE LESION WAS FAR BEYOND THE POSSIBLE ZONE OF LOCAL THERMAL DAMAGE. PROBE PLACEMENT AND USE SUBCUTANEOUSLY, WITH TISSUE EMBEDDING AND BLOCKAGE OF THE IRRIGATION, COULD HAVE ALSO POTENTIALLY CONTRIBUTED TO THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863977 TXB TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 04220-02-202201 00857156006093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other