BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11668773 · Received April 14, 2021

    Report

    Report Number
    1000135560-2021-00032
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    September 1, 2017
    Report Date
    April 14, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006215
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: SANCHEZ PJ, GRADY JF, SAXENA A. PERCUTANEOUS ULTRASONIC TENOTOMY FOR ACHILLES TENDINOPATHY IS A SURGICAL PROCEDURE WITH SIMILAR COMPLICATIONS, JOURNAL OF FOOT & ANKLE SURGERY 2017 SEP-OCT;56(5):982-984. THE ARTICLE WAS A SERIES OF 6 CASE REPORTS. REPORTED NON-RESOLUTION OF SYMPTOMS OR DISEASE STATE AFTER TREATMENT WITH THE TX SYSTEM WAS NOT INTERPRETED AS DEVICE-RELATED INJURY OR ADVERSE EVENTS. PROGRESSION OF A DETERIORATING CONDITION AFTER NON-RESOLUTION FROM TREATMENT WAS ALSO NOT INTERPRETED AS A DEVICE-RELATED INJURY OR ADVERSE EVENT. INFORMATION WAS NOT ADEQUATE TO DETERMINE IF TRANSVERSE MARKS AND LACERATIONS WERE ACTUAL INJURIES FROM TREATMENT WITH THE TX SYSTEM, GIVEN THE PREDOMINANCE OF THE PERSISTENT (LONGITUDINAL) ACHILLES TENDINOSIS, LIMITED INFORMATION ON THE PRESENTATION OF THE LACERATIONS, AND THE POSSIBILITY THAT THESE ARE NOT ATYPICAL OF NORMAL PERCUTANEOUS ULTRASONIC TREATMENT OF TENDINOSIS.

    Description of Event or Problem · 1

    A LITERATURE REVIEW DISCOVERED AN ARTICLE WHICH DESCRIBED AN ADVERSE EVENT POSSIBLY ASSOCIATED WITH USE OF THE TX SYSTEM (TX1 MICROTIP). THE ARTICLE WAS A SERIES OF CASE REPORTS. ONE CASE REPORTED DEVELOPMENT OF A DEEP VEIN THROMBOSIS IN A PATIENT 3 WEEKS AFTER TREATMENT OF THE ACHILLES TENDON WITH THE TX SYSTEM. ANTICOAGULATION THERAPY WAS ADMINISTERED. NO ADDITIONAL INFORMATION OR FOLLOW-UP WAS PRESENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560805 TX1 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-1003-001 NI 00857156006215

    Patients

    Seq Age Sex Outcome Treatment
    1