BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3770342 · Received January 21, 2014

    Report

    Report Number
    2085033-2014-00205
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 28, 2012
    Report Date
    January 18, 2014
    Manufacturer
    AOI, INC
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "WEEKLY COMPLAINT MEETING HELD, CLOSE COMPLAINTS 2000-2003 AND REFER TO CAPA (B)(4), THIS CAPA IS GOVERNING THE INVESTIGATION TO DETERMINE HOW TO IMPROVE DURATION FOR THE HANDPIECE TO STOP WORKING WOULD ONLY PROVIDE A MINOR INCONVENIENCE TO BOTH THE DOCTOR AND THE PT, THERE IS NO HARM IN THE UNIT IF IT STOPS CUTTING, THIS LOT IS PERFORMING WITHIN AN ACCEPTABLE PERCENTAGE RATE AND REQUIRES NO ADDITIONAL INVESTIGATION".

    Description of Event or Problem · 1

    ONE HAND PIECE WORKED FOR JUST UNDER 1 MINUTE AND THE SECOND WAND NEVER WORKED. THIRD WORKED FINE AND PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51329 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONICA SURGICAL ASPIRATION MGI LFL AOI, INC 29612-01

    Patients

    Seq Age Sex Outcome Treatment
    1