BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM-MICROTIP

    MDR report key: 3726599 · Received January 21, 2014

    Report

    Report Number
    2085033-2014-00230
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    January 10, 2013
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT NOT RETURNED FOR EVAL; THIS LOT HAS A (B)(4) COMPLAINT RATE; DHR REVIEW DOES NOT INDICATE A MFG ERROR; TWO COMPLAINTS FROM THIS FACILITY - NOT FACILITY OR TRAINING RELATED; WITHOUT AN EVAL THERE IS NO DETERMINATION OF MALFUNCTION CAUSE - UNIT NOT RETURNED FOR EVAL; UPDATED MDR FLOWCHART COMPLETED; THIS LOT HAS A (B)(4) COMPLAINT RATE; DHR REVIEW DOES NOT INDICATE A MFG ERROR; (B)(4) COMPLAINTS FROM THIS FACILITY - COULD BE A NEW FACILITY WITH A TRAINING ISSUE; 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

    ULTRASONIC ENERGY STOPPED LIKE THE HIP WAS CLOGGED, STARTED WORKING AGAIN AND THEN QUIT CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48300 TX1 TISSUE REMOVAL SYSTEM-MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 34712-05

    Patients

    Seq Age Sex Outcome Treatment
    1