BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11904839 · Received May 28, 2021

    Report

    Report Number
    1000135560-2021-00040
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    February 5, 2020
    Report Date
    October 22, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006215
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #01. ADDITIONAL INFORMATION WAS OBTAINED ON PATIENT'S OTHER RELEVANT HISTORY AND FURTHER MEDICAL CONSULTATIONS. ANOTHER PHYSICIAN REVIEWED MULTIPLE SOURCES OF TEST DATA FROM THE PATIENT'S AFFECTED ARM AND COULD NOT DETERMINE A SOURCE OF THE REPORTED SYMPTOMS (OR CONNECTION TO TREATMENT WITH THE TENEX HEALTH DEVICE).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS OBTAINED ON PATIENT'S OTHER RELEVANT HISTORY AND FURTHER MEDICAL CONSULTATIONS. PATIENT REPORTED A SEPARATE INJURY TO THE AFFECTED ARM AFTER TREATMENT WITH THE TENEX DEVICE. FOLLOW-UP IMAGING REVEALED A NERVE "IMPINGEMENT" RELATED TO THIS INJURY. IT WAS CONCLUDED THAT THE "PROCEDURE" WITH THE TENEX DEVICE WAS NOT RELATED TO THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 1

    A PATIENT REPORTED LOSS OF SOME ARM FUNCTION (PRONATION) A YEAR AFTER A PROCEDURE WITH THE TENEX HEALTH TX SYSTEM ON HIS ELBOW. THE TREATING PHYSICIAN DID NOT NOTE ANY ISSUES DURING THE PROCEDURE OR AT POST-OPERATIVE FOLLOW-UP. IT IS UNCLEAR IF THE PRESENT CONDITION IS RELATED TO THE PRIOR TREATMENT WITH THE TX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799609 TX1 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-1003-001 NI 00857156006215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other