BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670149 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00478
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    November 12, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROTIPS WERE DISPOSED OF BY THE FACILITY. THE UNITS WILL NOT BE RETURNED FOR EVAL. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE UNIT MALFUNCTION WITHOUT EVAL THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFO FOR A COMPLETE INVESTIGATION. THE DHR FOR MICROTIP LOT # 10613-01 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT UNIT. (B)(4).

    Description of Event or Problem · 1

    BOTH KITS, THE MICROTIP WAS NON-FUNCTIONAL. IT WOULD NOT PERFORM THE FUNCTION IT WAS SUPPOSED TO. THE THIRD KIT, THE TIP WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58291 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 10613-01

    Patients

    Seq Age Sex Outcome Treatment
    1