BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902347 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00073
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    July 17, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - "CUSTOMER STATED HANDPIECE FAILED TO PRIME 3 TIMES. UNIT PRIMED SUCCESSFULLY. COULD NOT VERIFY MALFUNCTION. CUTTING FUNCTION FAILED, BUT THIS IS MOST LIKELY DUE TO FLUID CAUSING HORN TO RUST". CUSTOMER WAS ABLE TO TIGHTEN THE CAP AND STRAIGHTEN TUBING AND THE UNIT PRIMED. 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 # 18712-06 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 5 UNITS THAT STOPPED WORKING AND 4 UNITS WOULD NOT PRIME. 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

    THEY WERE ABLE TO TIGHTEN CAP AND STRAIGHTEN TUBING AND SUCCESSFULLY PRIME THIS HANDPIECE AT OFFICE AFTER FAILING TO PRIME 3 TIMES DURING CASE TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114263 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 18712-06

    Patients

    Seq Age Sex Outcome Treatment
    1