BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3902865 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00499
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    February 11, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/23/2013 THE COMPLAINT UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION# (B)(4) - INFLATION CUFF WOULD NOT MAINTAIN PRESSURE. FOUND LOOSE PIPE THREAD ADAPTER ON PRESSURE REGULATOR ASSEMBLY. TUBING TENSION CAUSED FITTING TO VIBRATE LOOSE. RETIGHTENED AND RE-ROUTED TUBING TO RELEASE TENSION. REPACKAGE FOR REFURBISHED INVENTORY. ON 01/23/2014, THE DHR FOR CONSOLE S/N (B)(4) WAS REVIEWED AND SHOWED THAT THE UNIT 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 07/13/2013 THROUGH 12/13/2013 AND SHOWED THAT THIS WAS THE(B)(4) COMPLAINT REPORTED ORIGINATING FROM THIS CONSOLE. NO SIGNIFICANT TREND WAS OBSERVED. THE COMPLAINTS DATABASE WAS REVIEWED DURING THE MONTHS OF 7/13/2013 THROUGH 12/13/2013 AND SHOWED THAT THIS WAS THE (B)(4) COMPLAINT REPORTED FROM THIS FACILITY. NO SIGNIFICANT TREND WAS OBSERVED.

    Description of Event or Problem · 1

    INFLATION CUFF WILL NOT STAY INFLATED AND THE CUTTING TURNED OFF AT 67 SECONDS.....

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113436 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1