BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3726598 · Received January 21, 2014

    Report

    Report Number
    2085033-2014-00231
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Report Date
    January 18, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT NOT RETURNED FOR EVAL; UPDATED MDR FLOWCHART COMPLETED; THIS LOT HAS A (B)(4) COMPLAINT RATE: DHR REVIEW DOES NOT INDICATE A MFR ERROR; (B)(4) COMPLAINTS FROM THIS FACILITY - THIS DISTRIBUTOR HAS MANY FACILITIES, HARD TO CORRELATE PROBLEM; WITHOUT AN EVAL THERE IS NO DETERMINATION OF MALFUNCTION CAUSE - REFER TO CAPA (B)(4) INITIATED OCTOBER 2012 TO INVESTIGATED THE NUMEROUS STOPPED WORKING ISSUES (B)(4) 2013. A WAS RELEASED WITH RESULTS FOR THE VERIFICATION EFFECTIVENESS OF A LARGER ELECTRODE BEND RADIUS OF THE MICROTIP; THE INCREASED ELECTRODE BEND RADIUS INDICATED IMPROVED OUTPUT OF THE MANUFACTURING PROCESS AND ELIMINATION OF FAILURES DUE TO ELECTRODE BREAKAGE.

    Description of Event or Problem · 1

    STOPPED CUTTING DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49669 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 31112-05

    Patients

    Seq Age Sex Outcome Treatment
    1