BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3727949 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00286
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    May 8, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, 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

    CONSOLE EVALUATED, REFER TO (B)(4); TOUCHSCREEN UNRESPONSIVE. FOUND CRACKED SOLDER JOINT ON MAIN BOARD HEADER. REPAIRED. TOUCHSCREEN FUNCTIONS NORMALLY. RECOMMEND UPGRADE CONSOLE PER CAPA# (B)(4). THE DHR FOR CONSOLE S/N # (B)(4) WAS REVIEWED AND SHOWED THAT THE UNIT MET MFR SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. PER THE SENIOR CLINICAL MANAGER, MANY OF THE REPORTED COMPLAINTS COULD BE ATTRIBUTED TO USER ERROR DUE TO INEXPERIENCE WITH THE PROCEDURE. THIS CAUSE CANNOT BE VERIFIED. THE SENIOR CLINICAL MANAGER HAS SINCE BEEN TO THE FACILITY AND RETRAINED THE DOCTOR AND STAFF.

    Description of Event or Problem · 1

    THE CONSOLE WAS SET-UP WITH ALL CONNECTIONS. THE MICROTIP WAS PULLED FROM THE KIT AND SNAPPED INTO PLACE. THE CONSOLE WAS TURNED ON AND THE ATTEMPT WAS MADE TO PRIME THE NEEDLE, HOWEVER, THE TOUCH SCREEN WAS NOT FUNCTIONING. THE CONSOLE WAS TURNED OFF MULTIPLE TIMES TO SEE IF THERE WAS A MALFUNCTION ON TURNING ON THE MACHINE. THERE WAS NO CHANGE. ALL ATTACHMENTS WERE DETACHED WITH THE CONSOLE IN THE OFF POSITION, REATTACHED, AND THE CONSOLE TURNED ON WITH NO SUCCESS OR CHANGE IN THE OPERATING FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55129 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1