BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MICROSURGICAL SYSTEM

    MDR report key: 1000606 · Received February 15, 2008

    Report

    Report Number
    1920664-2008-00199
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 6, 2007
    Report Date
    December 6, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HNO
    PMA / PMN Number
    K913697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THIS UNIT SHUT DOWN. THE UNIT WAS REBOOTED AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM MICROSURGICAL SYSTEM OPHTHALMIC MICROSURGICAL UNIT HNO BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1