BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CCD DIGITAL CAMERA CONTROLLER NTSC/PAL

    MDR report key: 1185309 · Received September 26, 2008

    Report

    Report Number
    2028292-2008-00007
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    FWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: TO DATE AND EVALUATION OF THE RETURNED UNIT HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. ASSOCIATED REPORTS: MDR: 2028292-2008-00006, 202892-2008-00008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS CAMERA CONTROLLER WITH CAMERA HEAD IN A KNEE ARTHROSCOPY, IT STOPPED FUNCTIONING. ATTEMPTS TO TROUBLE SHOOT THE EQUIPMENT BY USING ANOTHER CAMERA CONSOLE AND CAMERA HEAD WERE UNSUCCESSFUL. THIS RESULTED IN CONVERTING TO AN OPEN PROCEDURE. THE CUSTOMER REPORTED THAT APPROXIMATELY A 45 MINUTES SURGICAL DELAY RESULTED AND THE PATIENT REQUIRED APPROXIMATELY 30 MINUTES ADDITIONAL RECOVERY TIME. THE PATIENT WAS DISCHARGED AS INTENDED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3CCD DIGITAL CAMERA CONTROLLER NTSC/PAL CAMERA CONTROLLER FWF CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention CATALOG #: IM3330| (B) (4)| NTSC 3CCD AUTOCLAVABLE EYECUP CAMERA HEAD