BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TXI TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727654 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00310
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    June 13, 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 # (B)(4) - CUSTOMER STATED "WOULD NOT CUT". UNIT PRIMED SUCCESSFULLY. FUNCTIONED WHEN ULTRASOUND POWER WAS APPLIED BUT CUTTING ACTION AND ACOUSTIC SIGNAL SOUNDED WEAK. SWEEP INDICATES NORMAL FREQUENCE OF 26.90 KHZ, HOWEVER, THE WAVE FORM INDICATES POOR CRYSTAL PERFORMANCE. OPENED MICROTIP TO FIND A SMALL CHIP ON ONE OF THE PIEZO CRYSTALS. ATTRIBUTE LOW ACOUSTIC SIGNAL AND POOR CUTTING ACTION TO CRACKED CRYSTAL. THE DHR FOR MICROTIP LOT 11613-06 WAS REVIEWED. 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. THIS WAS THE ONLY REPORTED MICROTIP UNIT FAILURE FROM THIS LOT. LOT 11613-06 HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    WHEN TESTING MICROTIP, SOUND WAS VERY MUFFLED AT FIRST, THE SOUNDED NORMAL. PRIMING WAS SUCCESSFUL. WHEN INSERTED INTO PATIENT AND ATTEMPTED TO START PROCEDURE, MIRCROTIP WOULD NOT WORK AT ALL. (NO SOUND, NO VIBRATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54329 TXI TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 11613-06

    Patients

    Seq Age Sex Outcome Treatment
    1