BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTOP

    MDR report key: 3670115 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00423
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    October 17, 2013
    Report Date
    January 21, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROTIP WAS DISPOSED OF. CANNOT VERIFY AN ASSIGNABLE CAUSE FOR THE MALFUNCTION WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR MICROTIP LOT 19713-04 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    UPON INSERTION OF THE TIP THERE WAS NO CUTTING. (DR. (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58209 TX1 TISSUE REMOVAL SYSTEM - MICROTOP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 19713-04

    Patients

    Seq Age Sex Outcome Treatment
    1