BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902895 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00549
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 14, 2014
    Manufacturer
    TENEX HEAL
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO PRIME WATER LEAKED EVERYWHERE, BAG OVERFILLED. OPENED A 2ND KIT TRIED TO PRIME. SAME THING HAPPENED. CONTACTED REP HOWEVER HE WAS UNAVAILABLE. CONTACTED CUSTOMER SUPPORT AND OPENED 3RD KIT AND IT WOULD NOT PRIME WHILE I WAS ON THE PHONE WITH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113550 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEAL 36113-02

    Patients

    Seq Age Sex Outcome Treatment
    1