BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3902860 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00523
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    December 23, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2014 UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION #(B)(4)- CUSTOMER STATED THAT THE TOUCH SCREEN WAS UNRESPONSIVE. SCREEN WAS CLEANED AND FUNCTIONED PROPERLY. COULD NOT DETERMINE CAUSE OF STATED MALFUNCTION. RECOMMEND RETEST AND RETURN TO CUSTOMER. (B)(6) 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. CONSOLE HISTORY ((B)(4)) WAS REVIEWED DURING THE MONTHS OF AUGUST 10, 2013 THROUGH JANUARY 10, 2014 AND SHOWED THAT THERE WERE NO REPORTED MICROTIP UNIT FAILURES ORIGINATING FROM THIS CONSOLE. ALSO THIS WAS THE FIRST AND ONLY TIME THIS UNIT WAS EVALUATED FOR A COMPLAINT. NO SIGNIFICANT TREND WAS OBSERVED. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF AUGUST 10, 2013 THROUGH JANUARY 10, 2014 AND SHOWED THAT THIS WAS THE FIRST AND ONLY REPORTED COMPLAINT FROM THIS FACILITY. NO SIGNIFICANT TREND WAS OBSERVED. FURTHER REVIEW OF THE COMPLAINTS DATABASE SHOWED THAT TO DATE THERE ARE (B)(4) REPORTED CONSOLE COMPLAINTS DUE TO TOUCHSCREEN FAILURES. CAPA (B)(4) WAS OPENED TO ADDRESS THE CONSOLE TOUCHSCREEN MALFUNCTION.

    Description of Event or Problem · 1

    THE BUTTONS FOR CUT AND ASPIRATION ARE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113138 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1