BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM-MICROTIP

    MDR report key: 3727895 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00312
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    June 14, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AOI, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "WAS VOIDED BECAUSE THE ALLEGED COMPLAINT UNIT WAS DISPOSED OF. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE ISSUE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 10213-07 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 10213-07. THERE WERE (B)(4) REPORTED MICROTIP UNIT FAILURES FROM THIS LOT. LOT 10213-07 HAS A FAILURE RATE OF (B)(4). PER THE SALES REP, THE CUSTOMER WAS NOT USING A COMPRESSION CUFF, WHICH CAN LOWER THE PSI OF THE BAG. THIS CAUSE CANNOT BE VERIFIED. THE REP ALSO STATED THAT WHEN THE UNITS STOP CUTTING, THE STAFF IMMEDIATELY INSTALLS A NEW CARTRIDGE WITHOUT TRYING TO TROUBLESHOOT THE UNIT."

    Description of Event or Problem · 1

    PRIME SUCCESSFUL AND THEN THE TX1 WOULD NOT OPERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54853 TX1 TISSUE REMOVAL SYSTEM-MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 10213-07

    Patients

    Seq Age Sex Outcome Treatment
    1