BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3880741 · Received April 9, 2014

    Report

    Report Number
    2085033-2014-00556
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    December 17, 2013
    Report Date
    April 9, 2014
    Manufacturer
    TENEX HEALTH
    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

    THE USER OBSERVED A CRACK IN THE CLEAR CASING. EVALUATION OF THE RETURNED UNIT CONFIRMED A CRACK IN THE PLASTIC CASING COMPROMISING UNIT STERILITY. NO STRESS MARKS INDICATING INTERNAL PRODUCT CONTENTS CAUSED CRACK OR PUNCTURE WERE OBSERVED. APPEARS TO HAVE BEEN EXTERNAL FORCE AFTER THE TRAY WAS REMOVED FROM THE CHIPBOARD BOX. THE UNIT WAS RETURNED IN THE ORIGINAL TRAY WITH THE SEAL STILL ATTACHED. THE UNIT WAS NEVER USED ON A PATIENT. THIS COMPLAINT IS STILL UNDER INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE CRACK. CURRENTLY BELIEVED TO BE CAUSED BY ENVIRONMENTAL CONDITIONS (I.E. TEMPERATURE IN EXTREME COLD).

    Description of Event or Problem · 1

    CLEAR PACKAGING WAS CUT COMPROMISING THE INNER CONTENTS STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213386 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 30913-07

    Patients

    Seq Age Sex Outcome Treatment
    1