BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3902839 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00528
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 15, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/20/2014 UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION #(B)(4) - UNIT PRIMED AND FUNCTIONED WITHIN ALL SPECIFICATIONS, HOWEVER, THE IRRIGATION VALVE PLUNGER WAS SLIGHTLY STIFF WHEN DEPRESSED. BINDING MAY CAUSE THE VALVE TO SEIZE CAUSING UNSUCCESSFUL PRIMING. RECOMMEND REPLACING IRRIGATION VALVE AS A PRECAUTION. REPLACED IRRIGATION VALVE WITH LOT #13013-04. CHECKED AND TESTED. UNIT FUNCTIONS WITHIN ALL SPECIFICATIONS. REP IS REQUESTING A DIFFERENT CONSOLE. REFURBISH CONSOLE AND RETURN TO DEMO STOCK. ON 02/13/2014 THE DHR FOR CONSOLE S/N (B)(4) WAS REVIEWED AND SHOWED THAT THE UNIT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. A REVIEW OF CONSOLE HISTORY (S/N (B)(4)) WAS PERFORMED DURING THE MONTHS OF AUGUST 16, 2013 THROUGH JANUARY 16, 2014 AND SHOWED THAT THERE WAS (B)(4) COMPLAINT REPORTED RELATED TO MICROTIP FAILURES ORIGINATING FROM THIS CONSOLE. NO SIGNIFICANT TREND WAS OBSERVED. THIS COMPLAINT WAS THE FIRST TIME THIS UNIT WAS EVALUATED AND SERVICED DUE TO A COMPLAINT. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF AUGUST 16, 2013 THROUGH JANUARY 16, 2014 AND SHOWED THAT THERE WERE (B)(4) REPORTED COMPLAINTS FROM THIS FACILITY.

    Description of Event or Problem · 1

    AS I ATTEMPTED TO PRIME, COULD NOT GET GUI TO TURN ON IRRIGATION, OR ANY OTHER FUNCTION. TURN MACHINE ON AND OFF...NO DIFFERENCE. SWITCHED OUT MACHINE AND PROCEEDED WITH CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113137 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1