BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOCAL SYSTEM - MICROTIP

    MDR report key: 3727880 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00319
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    June 25, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # (B)(4) - CUSTOMER STATED HANDPIECE WOULD NOT CUT. UNIT PASSED PRIMING CYCLE SUCCESSFULLY. VERIFIED THAT HANDPIECE WOULD NOT CUT. INTERNAL INSPECTION REVEALED SMALL AMOUNTS OF CORROSION/ MOISTURE AND COMPRESSION NUT/CRYSTAL STACK. APPEARS INTERNAL O-RING AND LOCTITE SEAL FAILED CAUSING A SHORT CAUSED BY MOISTURE. THE DHR FOR LOT 12113-02 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 12113-02. THERE WERE (B)(4) REPORTED UNIT FAILURES DUE TO FUNCTIONALITY. THIS LOT HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    NO CUTTING POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54468 TX1 TISSUE REMOCAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 12113-02

    Patients

    Seq Age Sex Outcome Treatment
    1