BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVUS 2000

    MDR report key: 560759 · Received December 21, 2004

    Report

    Report Number
    2914019-2004-00025
    Event Type
    Injury
    Date Received
    December 21, 2004
    Date of Event
    October 6, 2004
    Report Date
    December 17, 2004
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S NOVUS 2000 FAILED DURING AN ATTEMPTED VITRECTOMY TO THE LEFT EYE AFTER PASSING FUNCTIONAL TEST PRIOR TO THE SURGERY. THE PHYSICIAN STATED THAT THE PT MAY NOT REGIME VISION IN THE LEFT EYE DESPITE ATTEMPTING TO COMPLETE THE PROCEDURE WITH AN IRIS DIODE LASER. CUSTOMER STATED THAT AS OF 10/21/2004, ADDITIONAL PROCEDURES HAVE BEEN NEEDED.

    Description of Event or Problem · 1

    THE MFR RECEIVED A COPY OF THE CUSTOMER'S USER FACILITY MDR REPORT IN 11/04. THE CUSTOMER'S NOVUS 2000 FAILED ABOUT SIX WEEKS EARLIER DURING AN ATTEMPTED VITRECTOMY TO THE LEFT EYE AFTER PASSING FUNCTIONAL TEST PRIOR TO THE SURGERY. THE PHYSICIAN STATED THAT THE PT MAY NOT REGAIN VISION IN THE SURGERY. THE PHYSICIAN STATED THAT THE PT MAY NOT REGAIN VISION IN THE LEFT EYE DESPITE ATTEMPTING TO COMPLETE THE PROCEDURE WITH AN IRIS DIODE LASER. CUSTOMER STATED THAT AS OF 10/04, ADDITIONAL PROCEDURES HAVE BEEN NEEDED. AS OF 12/04, CUSTOMER HAS NOT PROVIDED OBJECTIVE CLINICAL DATA TO SUBSTANTIATE THE STATMENTS MADE IN THEIR MDR REPORT. MFR IS CONTINUING TO REQUEST SAID CONFIRMATION FROM THE CUSTOMER AND WILL CONTINUE TO FURTHER THE INVESTIGATION UPON RECEIPT OF SAID INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS 2000 OPHTHALMIC LASERS GEX COHERENT MEDICAL GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention INCIDENT.| PROCEDURE WITH IRIS DIODE LASER ON DATE OF| PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO COMPLETE THE