BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE SCROLL MILLENNIUM SYSTEM

    MDR report key: 2960541 · Received February 12, 2013

    Report

    Report Number
    1920664-2013-00017
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K961310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THE SYSTEM WAS TESTED ON-SITE BY A BAUSCH AND LOMB SERVICE TECHNICIAN AND WAS FOUND TO FUNCTION PROPERLY. THE TECHNICIAN REPORTED THAT THE CUSTOMER HAD FAILED TO SECURE THE POWER CABLE WITHIN THE MOUNTED POWER CABLE FIXATION HOLDER AFTER THE INSTALLATION OF THE COMPUTER. THE TECHNICIAN REDIRECTED THE POWER CABLE TO THE CORRECT POSITION.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATES: "THE MACHINE SWITCHED OFF DURING SURGERY. SOME IMPACT ON VISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61300 ELITE SCROLL MILLENNIUM SYSTEM HQC BAUSCH & LOMB, INC. CX3200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other