BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902866 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00498
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    December 11, 2014
    Report Date
    February 11, 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

    ON (B)(6) 2013 COMPLAINT UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # MT00388 - NO NOTABLE DEFECTS DURING VISUAL INSPECTION. DURING TESTING RECEIVED "FLUID PATH BLOCKED" ERROR MESSAGE. UPON INTERNAL INSPECTION, EXCESSIVE LOCTITE WAS FOUND IN THE CENTRAL BOLT. 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. THERE WERE (B)(4) UNITS RELEASED FROM MICROTIP LOT 28013-05. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE (B)(4) REPORTED MICROTIP UNIT FAILURES. LOT 28013-05 HAS A FAILURE RATE OF (B)(4)%. NO SIGNIFICANT TREND WAS OBSERVED. UPON REVIEW OF THE COMPLAINTS FROM THIS FACILITY, IT WAS VERIFIED THAT THE CAUSE OF FAILURE FOR THE MICROTIPS WERE DUE TO ISSUES WITH THE UNIT ITSELF. ALL COMPLAINTS WERE VERIFIED AND THERE WAS NO INDICATION OF ANY CONSOLE MALFUNCTION OR CUSTOMER MISUSE.

    Description of Event or Problem · 1

    FLUID PATH BLOCKED, WOULD NOT PRIME. (DR. (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113540 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 28013-05

    Patients

    Seq Age Sex Outcome Treatment
    1