BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902884 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00500
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    December 13, 2013
    Report Date
    February 11, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 DATE OF INCIDENT. DURING PROCEDURE. NO INJURIES DUE TO THE UNIT FAILURE. ON (B)(6) 2013 THE COMPLAINT UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION# (B)(4) - VISUALLY, NO DEFECTS WERE NOTED. HANDPIECE PRIMED AND CUT SUCCESSFULLY. DISASSEMBLED UNIT TO VERIFY INTERNAL COMPONENTS. NO DAMAGE OR DEFECT NOTED. COULD NOT DUPLICATE MALFUNCTION. HANDPIECE WAS DISCARDED AFTER TESTING. ON (B)(4) 2014, A REVIEW OF CONSOLE HISTORY (S/N (B)(4)) WAS PERFORMED DURING THE MONTHS OF (B)(4) 2013 AND SHOWED THAT (B)(4) REPORTED COMPLAINTS ORIGINATING FROM THIS CONSOLE. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF (B)(4) 2013 AND SHOWED THAT THERE WERE (B)(4) COMPLAINTS REPORTED FROM THIS FACILITY. IN LIEU OF REQUESTING THE CONSOLE BACK FOR EVALUATION, AN EMAIL WAS SENT TO THE SALES REP ON (B)(4) 2013 INFORMING THEM OF THE AMOUNT OF COMPLAINTS RECEIVED FROM THIS FACILITY AND TO ADVISE THEM TO RETRAIN THE FACILITY. SINCE THE EMAIL, THE RATE OF COMPLAINTS REPORTED FROM THIS FACILITY HAVE DECREASED. THERE HAVE BEEN TWO (2) REPORTED COMPLAINTS SINCE ALERTING THE SALES REP. THE FACILITY AND CONSOLE WILL CONTINUE TO BE MONITORED FOR FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    IN THE MIDDLE OF PROCEDURE HAND PIECE STOPPED CUTTING. CHECKED EVERYTHING EVEN REPRIMED AND STILL NO RESULTS. HAD TO USE ANOTHER KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113524 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 26113-06

    Patients

    Seq Age Sex Outcome Treatment
    1