BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902328 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00075
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    July 20, 2012
    Report Date
    February 16, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO SERVICE RECORD - GENERAL EVAL # (B)(4), BOTH UNITS PRIMED AND FUNCTIONED PROPERLY. BASED UPON THE CUSTOMER COMPLAINT, WE BELIEVE THAT THE CASSETTES WERE NOT PROPERLY LOCKED INTO THE CONSOLE ALLOWING IRRIGATION TO FLOW FREELY ONCE THE INFLATION CUFF WAS INFLATED. ON (B)(4) 2014: OPENED CAPA (B)(4) TO REVIEW 2012 COMPLAINTS. UPDATED WITH THE FOLLOWING DETAILS: COMPLETED AND ATTACHED A CURRENT MDR DECISION FLOWCHART. THE DHR FOR LOT # 17412-01 WAS REVIEWED. THE UNIT MET MFG SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THIS LOT HAS A (B)(4) COMPLAINT RATE. THERE WERE (B)(4) UNITS RELEASED TO DISTRIBUTION. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE A TOTAL OF 3 UNITS THAT STOPPED WORKING. A REVIEW OF THE CONSOLE HISTORY WAS NOT PERFORMED BECAUSE THE CONSOLE SERIAL NUMBER WAS NOT REPORTED WITH THE COMPLAINT.

    Description of Event or Problem · 1

    VACUUM TEST FAILED WHEN TRYING TO PRIME. INFLATION FILLED UP ALMOST IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113531 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 17412-01

    Patients

    Seq Age Sex Outcome Treatment
    1