BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 7295453 · Received February 26, 2018

    Report

    Report Number
    1000135560-2018-00010
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 25, 2018
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K153299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OF THE TX2 MICROTIPS, PART NUMBER: 554-2003-001, WERE INVOLVED IN THIS INCIDENT. THE FIRST ONE WAS FROM LOT NUMBER: 17417-01-201811, MANUFACTURED ON 9/21/2017, EXPIRATION DATE: 11/30/2018. THE SECOND ONE WAS FROM LOT NUMBER: 07917-02, MANUFACTURED ON 4/20/2017, EXPIRATION DATE: 2/28/2018. BOTH NEEDLES WERE RETURNED AND EVALUATED BY TENEX HEALTH. FAILURES WERE CONFIRMED FOR BOTH PARTS. DUE TO THE STATE IN WHICH THE DEVICES WERE RECEIVED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE FRACTURE SITES DID NOT INDICATE A SPECIFIC CAUSE FOR THE FAILURES. DISASSEMBLY OF THE DEVICES DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS.

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH THE TENEX SYSTEM, TWO MICROTIP NEEDLES SEPARATED FROM THE REST OF THE HAND PIECES WHILE PERFORMING THE PROCEDURE. THE NEEDLES WERE CAREFULLY RETRIEVED FROM THE PATIENT AND DISCARDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROTIP HAND PIECE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139697 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 17417-01-201811, 07917-02

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR