BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3902874 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00494
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    December 12, 2013
    Report Date
    February 11, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/20/2013 COMPLAINT UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION# (B)(4) - TOUCHSCREEN INTERMITTENT AFTER UNIT WAS TURNED ON FOR AN EXTENDED PERIOD OF TIME. FOUND "COLD" SOLDER JOINT ON MAIN BOARD HEADER. COULD NOT DETERMINE CAUSE OF CRACKED SOLDER JOINT. REPAIRED SOLDER JOINT TO FINISH EVALUATION. UNIT FUNCTIONED WITHIN ALL OTHER SPECIFICATIONS. RESOLDERED HEADER CONTACTS ON MAIN BOARD. CHECKED AND TESTED. ON 01/07/2014, RGA COOR. VOIDED RGA (B)(4), AS IT IS A DUPLICATE OF RGA (B)(4). ON 01/23/2014, THE DHR CONSOLE S/N (B)(4) WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. A REVIEW OF CONSOLE HISTORY (S/N (B)(4)) WAS PERFORMED DURING THE MONTHS OF 07/12/2013 THROUGH 12/12/2013 AND SHOWED THAT THIS UNIT WAS EVALUATED ON 11/25/2013 FOR THE SAME ISSUE. A REVIEW OF THE COMPLAINTS DATABASE SHOWED THAT TO DATE THERE ARE (B)(4) REPORTED CONSOLE COMPLAINTS DUE TO TOUCHSCREEN FAILURE. CAPA (B)(4) WAS OPENED TO ADDRESS THE CONSOLE TOUCHSCREEN MALFUNCTION.

    Description of Event or Problem · 1

    TOUCH SCREEN IS STILL NOT FUNCTIONING PROPERLY. CONSOLE WAS SENT IN PREVIOUSLY AND THE REPORTED MALFUNCTION COULD NOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113515 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1