BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENIUM MICROSURGICAL SYSTEM

    MDR report key: 819141 · Received February 9, 2007

    Report

    Report Number
    MW1041930
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    February 7, 2007
    Report Date
    February 9, 2007
    Manufacturer
    BAUSCH & LOMB SURGICAL, INC
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MILLENIUM MICROSURGICAL SYSTEM MANUFACTURED BY BAUSCH & LOMB, INC WAS BEING UTILIZED ON A PT DURING A SURGICAL PROCEDURE IN OUR OPERATING SUITE. ONCE THE PROCEDURE HAD STARTED, THE ATTACHMENTS WERE CONNECTED; HOWEVER, THE MACHINE WOULD NOT ALLOW THE PHYSICIAN TO CONTINUE WITH THE PROCEDURE. THE SYSTEM DISPLAYED NOTED THAT THE CARTRIDGE WAS FULL, WHEN, INDEED, IT WAS NOT. NONETHELESS, THE CARTRIDGE WAS EXCHANGED, AND TROUBLESHOOTING PERFORMED BY THE PHYSICIAN WITHOUT SUCCESS. A REP FOR THE EQUIPMENT WAS THEN NOTIFIED VIA TELEPHONE AND WAS UNABLE TO ASSIST WITH DIAGNOSING OR CORRECTING THE MALFUNCTION. THE SURGICAL CASE WAS CANCELLED IN ADDITION TO THE REMAINING PERTINENT SURGICAL CASES. THE PT SUFFERED NO ILL EFFECTS; HOWEVER, A LETTER WAS SENT TO BAUSCH & LOMB, INC REQUESTING A RESPONSE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENIUM MICROSURGICAL SYSTEM * HQE BAUSCH & LOMB SURGICAL, INC CX6100, 101-028-040 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *