BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727856 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00294
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    May 21, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AOI
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS NOT BEEN RECEIVED FROM THE FIELD. THE FACILITY STATED THEY NO LONGER HAVE THE COMPLAINT UNIT. THE ALLEGED COMPLAINT UNIT WILL NOT BE RETURNED FOR EVALUATION. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE FAILURE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 10613-01 WAS REVIEWED. THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FROM LOT 10613-01. THERE WAS ONLY (B)(4) REPORTED MICROTIP UNIT FAILURE FROM THIS LOT HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    UPON PRIMING THE UNIT THE PRIME UNSUCCESSFUL MESSAGE CAME UP. TRIED TO REPRIME AND THE VACUUM MESSAGE RESULTED. WE OPENED ANOTHER TX-1 AND IT PRIMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54868 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI 10613-01

    Patients

    Seq Age Sex Outcome Treatment
    1