BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902317 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00080
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    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

    ON 07/27/2012: UNIT NOT RETURNED DUE TO PT CONTACT. ON 07/27/2012: MDR FLOWCHART COMPLETED, NOT REPORTABLE. ON 01/26/2013: COMPLAINT CLOSED. ON 02/04/2014: OPENED CAPA (B)(4) TO REVIEW 2012 COMPLAINTS. UPDATED WITH THE FOLLOWING DETAILS: THE UNIT HAD MADE PT CONTACT AND WAS NOT RECEIVED FOR EVAL. IT IS NOT POSSIBLE TO DETERMINE AN ASSIGNABLE CAUSE FOR THIS ISSUE. THERE IS INSUFFICIENT INFO FOR A COMPETE INVESTIGATION. COMPLETED AND ATTACHED A CURRENT MDR DECISION FLOWCHART. THE DHR FOR LOT # 19812-03 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 (B)(4) UNITS THAT STOPPED WORKING. FAILURE POSSIBLY DUE TO AN ELECTRODE BREAKING, REFER TO CAPA (B)(4). 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

    CUTTING ON THE HANDPIECE FROZE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113525 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 19812-13

    Patients

    Seq Age Sex Outcome Treatment
    1