BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TXL TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670134 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00439
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    November 1, 2013
    Report Date
    January 21, 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

    UNIT WAS RECEIVED FROM THE FIELD FOR EVAL. REFER TO EVAL # (B)(4) - CAP WAS VERY HARD TO REMOVE. HANDPIECE FUNCTIONED WITHIN ALL SPECS. THE ASSIGNABLE CAUSE OF THE UNIT FAILURE WAS DUE TO A MFG ISSUE. THE DHR FOR FAILURE WAS DUE TO A MFG ISSUE. THE DHR FOR MICROTIP LOT 21813-01 WAS REVIEWED AND SHOWED THAT THE UNIT MET MFG SPECS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4). THIS COMPLAINT WAS DUE TO A MFG ISSUE AND THE UNIT'S FAILURE MODE DID NOT EFFECT THE FUNCTIONALITY OF THE UNIT.

    Description of Event or Problem · 1

    PLASTIC CAP ON TIP WOULD NOT COME OFF (SEAL WOULD NOT BREAK) (DR. (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58286 TXL TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AOI, INC. 21813-01

    Patients

    Seq Age Sex Outcome Treatment
    1