BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670121 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00470
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Report Date
    January 18, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "UNIT WAS RECEIVED FOR EVAL. REFER TO EVAL # (B)(4) - CONNECTOR PINS WERE SEVERELY BENT, CLEARLY FROM A FORCED CONNECTION. MICROTIP WAS DISPOSED OF. AN EMAIL WAS SENT TO THE SALES REP ADVISING HER TO REMIND THE FACILITY OF PROPER PROCEDURE WHEN SETTING UP THE CONSOLE. THE DHR FROM MICROTIP LOT# 12113-02 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    CONNECTOR PIN PRONGS WERE BENT MAKING THE CONNECTOR CORD UNABLE TO PLUG INTO THE CONSOLE. (DR (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58211 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 12113-02

    Patients

    Seq Age Sex Outcome Treatment
    1