BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902892 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00553
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 14, 2014
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE HAD GONE THROUGH THE SETUP PROCEDURE WHICH WENT FINE, NO ERROR MESSAGES. WHEN DR. SMITH INSERTED THE PROBEIT WOULD NOT CUT. HE MADE SEVERAL ATTEMPTS BEFORE WE OPENED A NEW KIT. THE NET KIT WORKED WITH NO ISSUE. WE CALED OUR REP AT THE TIME BUT WAS UNABLE TO CONTACT HER UNTIL AFTER THE HANDPIECE HAD GONE TO BIOHAZARD WASTE. WE DID NOT KNOW UNTIL TODAY THAT THE HANDPIECE IS SUPPOSED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114238 TX1 TISUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 33613-09

    Patients

    Seq Age Sex Outcome Treatment
    1