BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 7470814 · Received April 27, 2018

    Report

    Report Number
    1000135560-2018-00026
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    April 2, 2018
    Report Date
    May 21, 2018
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K153299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #01. THE DEVICE WAS RETURNED TO TENEX HEALTH, INC. THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. DUE TO THE STATE IN WHICH THE DEVICE WAS RECEIVED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE FRACTURE SITE DID NOT INDICATE A SPECIFIC CAUSE FOR THE FAILURE. DISASSEMBLY OF THE DEVICE DID NOT REVEAL ANY FURTHER ANOMALIES OR DEFECTS. A ROOT CAUSE INVESTIGATION AND CORRECTIVE ACTION PLAN ARE IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO TENEX. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. A ROOT CAUSE INVESTIGATION AND CORRECTIVE ACTION PLAN ARE IN PROCESS.

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH THE TENEX SYSTEM, THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THE NEEDLE WAS RETRIEVED AND DISCARDED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312371 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 31117-04-201812

    Patients

    Seq Age Sex Outcome Treatment
    1