BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MOCROTIP

    MDR report key: 3904819 · Received May 19, 2014

    Report

    Report Number
    3009750704-2014-00563
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON A F/U ON (B)(6) 2014, THE FACILITY STATED THAT THE HANDPIECE BECAME UNBEARABLE FOR THE DOCTOR (HEAT) AND THE PT COULD FEEL IT GETTING A LITTLE BIT WARM. NO SERIOUS INJURY OCCURRED TO THE PT AND THE DOCTOR COMPLETED THE PROCEDURE WITH ANOTHER MICROTIP. AWAITING FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    DURING PROCEDURE, SOUND HANDPIECE MAKES DECREASED, HANDPIECE NO LONGER FELT WARM. HANDPIECE REMOVED FROM PT, PT TEST DONE - IRRIGATION WAS PRESENT BUT NO SOUND PRESENT, THEN AFTER A FEW SECONDS SOUND RESUMED. ATTEMPTED TO FINISH PROCEDURE BUT ONCE INSERTED INTO PT, SOUND STOPPED, HANDPIECE NOT WORKING. REMOVED FROM PT. ADD'L HANDPIECE USED TO FINISHED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296340 TX1 TISSUE REMOVAL SYSTEM - MOCROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 04814-07

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR