BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670119 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00479
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 27, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT UNIT WAS RECEIVED FROM THE FIELD FOR EVAL. REFER TO EVAL # (B)(4) - NO NOTABLE DEFECTS DURING VISUAL INSPECTION. DURING TESTING RECEIVED "FLUID PATH BLOCKED" "ERROR MESSAGE. UPON INTERNAL INSPECTION, EXCESSIVE LOCTITE WAS FOUND IN THE COMPRESSION NET. HANDPIECE WAS DISPOSED OF ON (B)(6) 2014, THE DHR FOR MICROTIP LOT # 28013-05 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4). NO SIGNIFICANT TREND WAS OBSERVED. A REVIEW OF CONSOLE HISTORY (SN # (B)(4)) WAS PERFORMED DURING THE MONTHS OF (B)(4) 2013 AND SHOWED THAT THIS WAS THE FIRST AND ONLY REPORTED COMPLAINT ORIGINATING FROM THIS CONSOLE. NO SIGNIFICANT TREND WAS OBSERVED. A REVIEW OF THE COMPLAINTS DATABASE DURING THE MONTHS OF (B)(4) 2013 SHOWED THAT THERE WERE FOUR (4) COMPLAINTS REPORTED FROM THIS FACILITY. THE CONSOLE WAS NOT REQUESTED FOR EVAL BECAUSE THE COMPLAINTS REPORTED FROM THIS FACILITY DO NOT INDICATE ANY ISSUES WITH THE CONSOLE. THIS FACILITY WILL CONTINUE TO BE MONITORED FOR FUTURE REPORTED COMPLAINTS.

    Description of Event or Problem · 1

    THE IRRIGATION BLOCKED MESSAGE APPEARED 4 TIMES BUT THERE WAS NOTHING OCCLUDING THE GREEN TUBING AT AY POINT, FROM WHAT WE COULD TELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58285 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 28013-05

    Patients

    Seq Age Sex Outcome Treatment
    1