BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902896 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00548
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 28, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. (B)(4). NO VISUAL DEFECT NOTED. PRIMED SUCCESSFULLY, CUT FOR 18 SECONDS AND THEN GAVE "CHECK HANDPIECE" ERROR MESSAGE (TEST002). UPON INTERNAL INSPECTION A BROKEN JUMPER WAS DETECTED. HANDPIECE WAS DISCARDED. ON (B)(6) 2014 THE DHR FOR MICROTIP LOT 33813-05 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FROM MICROTIP LOT 33813-05. A REVIEW OF LOT HISTORY SHOWED THAT THERE WAS ONLY ONE (1) REPORTED MICROTIP UNIT FAILURE FROM THIS LOT. LOT 33813-05 HAS A FAILURE RATE OF (B)(4). NO SIGNIFICANT TREND WAS OBSERVED. A REVIEW OF CONSOLE HISTORY ((B)(4)) WAS PERFORMED DURING THE MONTHS OF 08/29/2013 THRU 01/29/2014 AND SHOWED THAT THERE WAS ONLY ONE REPORTED COMPLAINT ORIGINATING FROM THE CONSOLE. NO SIGNIFICANT TREND WAS OBSERVED. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF 08/29/2013 THROUGH 01/29/2014 AND SHOWED THAT THIS WAS THE FIRST AND ONLY COMPLAINT REPORTED FROM THIS FACILITY. NO SIGNIFICANT TREND WAS OBSERVED.

    Description of Event or Problem · 1

    WE USED THE TX MICROTIP FOR ABOUT 30 SECONDS OF POWER DURING THE CASE. IT THEN STOPPED WORKING. DISPLAY RED "CHECK HANDPIECE." TRIED ALL TROUBLESHOOTING. NOTHING WORKED. HAD TO SWAP OUT FOR A NEW HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113556 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 33813-05

    Patients

    Seq Age Sex Outcome Treatment
    1