BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3880768 · Received April 9, 2014

    Report

    Report Number
    2085033-2014-00560
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER OBSERVED A CRACK IN THE CLEAR CASING. THIS UNIT IS PENDING RETURN FOR EVALUATION. BASED ON SIMILAR COMPLAINTS OF THIS NATURE, THIS COMPLAINT IS CURRENTLY BELIEVED TO BE CAUSED BY ENVIRONMENTAL CONDITIONS., (I.E. TEMPERATURE IS EXTREME COLD).

    Description of Event or Problem · 1

    CRACKED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214084 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 32913-07

    Patients

    Seq Age Sex Outcome Treatment
    1