BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670116 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00484
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    December 6, 2013
    Report Date
    January 27, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # (B)(4) - LEAK IN THE TUBING AT THE BASE OF HANDPIECE WAS CONFIRMED. UPON INTERNAL INSPECTION, NO VISIBLE DEFECTS WERE NOTED. HANDPIECE WAS DISASSEMBLED AND DISCARDED. ON (B)(4) 2014 THE DHR FOR MICROTIP LOT 28013-05 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4). NO SIGNIFICANT TREND WAS OBSERVED. A REVIEW OF CONSOLE HISTORY (S/N (B)(4)) WAS PERFORMED DURING THE MONTHS OF (B)(4) 2013. THE CONSOLE WAS NOT REQUESTED BACK FOR EVALUATION BECAUSE MOST OF THE UNIT FAILURES REPORTED WERE VERIFIED TO BE CAUSE BY AN ISSUE WITH THE HANDPIECE ITSELF AND NOT THE CONSOLE. THERE WERE NO INDICATIONS THERE WERE ANY PROBLEMS WITH THE CONSOLE OR FACILITY TRAINING."

    Description of Event or Problem · 1

    NOTICED THAT THE TUBING WAS LEAKING DURING PRIMING - WOULD NOT WORK BECAUSE OF LEAKING FLUID FROM TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58254 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 28013-05

    Patients

    Seq Age Sex Outcome Treatment
    1