BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TXL TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670212 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00334
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    July 12, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER SERVICE, THE MICROTIP UNIT WAS DISPOSED OF. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE UNIT FAILURE WITHOUT EVALUATING THE COMPLAINT UNIT. INSUFFICIENT INFO FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 11613-06 WAS REVIEWED. THE UNITS MET MFG SPECS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    UPON INSERTION OF THE TOP OF NEEDLE IT HAD NO CUTTING POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58282 TXL TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 11613-06

    Patients

    Seq Age Sex Outcome Treatment
    1