BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727617 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00304
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    May 6, 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
    NC, 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 THE HANDPIECE HAS STOPPED CUTTING POWER. MICROTIP RECEIVED WITH NO CABLE OR CASSETTE. FOUND A CRACKED PIEZO CRYSTAL UPON INTERNAL INSPECTION. POOR SWEEP (FREQUENCY, PHASE, BANDWIDTH) DUE TO CRACKED CRYSTAL. COULD NOT VERIFY CAUSE OF CRACK. THE DHR FOR LOT 02413-04 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 02413-04. A REVIEW OF LOT HISTORY AT THIS TIME SHOWED THAT THIS COMPLAINT WAS AN ISOLATED INCIDENT WITHIN THIS LOT.

    Description of Event or Problem · 1

    STOPPED CUTTING DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54464 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 02413-04

    Patients

    Seq Age Sex Outcome Treatment
    1