BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM-MICROTIP

    MDR report key: 3727871 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00370
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    August 14, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AOI, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # MT00296- "CHECK HANDPIECE" MESSAGE DISPLAYED. COULD NOT VERIFY CAUSE OF PROBLEM THROUGH CONTINUITY OR VISUAL INSPECTION. POOR SWEEP; OUT OF PHASE. SUSPECT CRYSTAL STRESS WAS ROOT CAUSE OF FAILURE. THE DHR FOR MICROTIP LOT 11613-06 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 LOT 11613-06. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE (B)(4) REPORTED MICROTIP UNIT FAILURES. LOT 11613-06 HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    ON WEDNESDAY WE ONCE AGAIN EXPERIENCED A HAND PIECE FAILURE. WE TRIED TO RE-PRIME THE UNIT AS WE HAVE BEEN SHOWN; HOWEVER, THE UNIT CONTINUED TO DISPLAY "CHECK HAND PIECE". WE PLACED A CALL TO OUR SALES REPRESENTATIVE FOR ASSISTANCE; HOWEVER, SHE IS ON VACATION AND WE WERE FORCED TO OPEN A SECOND TX1 TISSUE REMOVAL SYSTEM TO COMPLETE THE CASE WHICH FUNCTIONED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54836 TX1 TISSUE REMOVAL SYSTEM-MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AOI, INC. 11613-06

    Patients

    Seq Age Sex Outcome Treatment
    1