BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICTROTIP

    MDR report key: 3902876 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00547
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 16, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 UNIT WAS DISPOSED OF BY THE FACILITY. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE UNIT FAILURE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFO FOR A COMPLETE INVESTIGATION. THE DHR FOR MICROTIP LOT 32413-01 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 32413-01. A REVIEW OF LOT HISTORY SHOWED THAT THIS WAS THE FIRST AND ONLY REPORTED MICROTIP UNIT FAILURE FROM THIS LOT. LOT 32413-01 HAS A FAILURE RATE OF (B)(4). NO SIGNIFICANT TREND WAS OBSERVED. THE CONSOLE HISTORY WAS REVIEWED ((B)(4)) DURING THE MONTHS OF SEPTEMBER 29, 2014 THROUGH JANUARY 29, 2014 AND SHOWED THAT THERE WERE TWO (2) REPORTED COMPLAINTS DURING THIS TIME PERIOD. NO SIGNIFICANT TREND WAS OBSERVED. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF SEPTEMBER 29, 2014 THROUGH JANUARY 29, 2014 AND SHOWED THAT THIS FACILITY REPORTED TWO (2) COMPLAINTS DURING THIS TIME PERIOD. NO SIGNIFICANT TREND WAS OBSERVED.

    Description of Event or Problem · 1

    HAND DEVICE WOULD ONLY CUT FOR ABOUT 1/2 SECOND THE SHUT OFF SCREEN WOULD SAY SOMETHING ABOUT HANDPIECE. WE TRIED REPRIMING THE HANDPIECE AND IT WOULD ONLY CUT FOR 2 OR 3 SECONDS AND THEN START MALFUNCTION AGAIN. WE ENDED UP OPEN UP ANOTHER KIT SINCE THE PATIENT HAD BEEN WAITING SO LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113595 TX1 TISSUE REMOVAL SYSTEM - MICTROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 32413-01

    Patients

    Seq Age Sex Outcome Treatment
    1