BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3902877 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00546
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 24, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 UNIT WAS REC'D FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # (B)(4) FAILED ELECTRICAL SAFETY TESTING AS WAS STATED BY CUSTOMER. OPENED UNIT TO FIND THAT ONE LOCK NUT ON THE EQUIPOTENTIAL GROUND STUD HAD COME LOOSE. SIDE PLATE GROUND WIRE SLIGHTLY LOOSE. RE-TIGHTENED NUT ACCORDING TO SPECS. RETESTED. PASSED ALL TESTS. WENT THROUGH ALL GROUNDS. FOUND AC INLET GROUND WIRE CONNECTIONS WERE LOOSE (SIDE PANEL GROUND WIRE). RETIGHTENED, CHECKED AND TESTED. ON (B)(4) 2014 THE DHR FOR CONSOLE (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 ((B)(4)) WAS PERFORMED DURING THE MONTHS OF AUGUST 27, 2013 THROUGH JANUARY 27, 2014 AND SHOWED THAT THERE WERE NO REPORTED MICROTIP UNIT FAILURE ORIGINATING FROM THIS LOT. THIS WAS ALSO THE FIRST TIME THIS UNIT WAS EVALUATED AND SERVICE DUE TO A FACILITY COMPLAINT. NO SIGNIFICANT TRENDS WERE OBSERVED. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF AUGUST 27, 2013 THROUGH JANUARY 27, 2014 AND SHOWED THAT THIS WAS THE FIRST AND ONLY COMPLAINT EVER REPORTED FROM THIS FACILITY. NO SIGNIFICANT TREND WAS OBSERVED.

    Description of Event or Problem · 1

    CONSOLE FAILED BIOMED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113516 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1