BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 6038836 · Received October 19, 2016

    Report

    Report Number
    3009750704-2016-00015
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 18, 2016
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH THE NEEDLE SEPARATED FROM THE MICROTIP. BOTH THE NEEDLE AND THE NOSE CONE WERE BENT INDICATING SIDE LOAD FORCES HAD BEEN APPLIED. NO OTHER DAMAGE OR DEFECT WAS NOTED ON INITIAL INSPECTION. DUE TO THE NEEDLE BEING SEPARATED FROM THE HORN, FUNCTIONAL TESTING COULD NOT BE PERFORMED. DISASSEMBLY OF THE MICROTIP FOUND THAT THE NEEDLE HAD BROKEN OFF THE HORN AND BRAZE JOINT WHICH IS THE HIGHEST STRESS POINT ALONG THE NEEDLE. DUE TO THE FACT THAT THE NEEDLE AND CASE NOSE WERE BOTH BENT, IT IS SUSPECTED THAT SIDE LOAD FORCES WERE APPLIED TO THE NEEDLE CAUSING IT TO BEND AND SUBSEQUENTLY BREAK OFF AT THE HIGHEST STRESS POINT. THE PREMATURE NEEDLE FAILURE IS ATTRIBUTED TO IMPROPER TECHNIQUE. THERE WAS NO INDICATION OF OFF-LABEL USE OR USE ON HARD TISSUE. PER THE INFORMATION FROM THE CONTACT, THERE WAS NO INJURY OR COMPLICATION TO THE PATIENT CAUSED BY THE FAILURE. A SECOND MICROTIP WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    PER THE INFORMATION PROVIDED, DURING A PROCEDURE THE NEEDLE OF THE MICROTIP BROKE OFF IN THE PATIENT. IT WAS AT THE ENTRY POINT OF THE INCISION AND WAS REMOVED BY THE DOCTOR. ANOTHER MICROTIP WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691005 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 22916-06

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other