BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA PRO XENON LIGHT SOURCE

    MDR report key: 3788472 · Received April 2, 2014

    Report

    Report Number
    8010047-2014-00132
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 5, 2014
    Report Date
    January 6, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE PHENOMENON WAS NOT REPRODUCED, BUT DUST WAS FOUND WITHIN AND THE BOTTOM OF THE SUBJECT DEVICE. THERE IS THE POSSIBILITY THAT THE DUST WAS ON THE TURRET AND THE APERTURE WHICH CAUSE A TEMPORARY DARKNESS OF THE IMAGE, AND THE POSSIBILITY OF THE INCOMPLETE CONNECTION BETWEEN THE CONNECTOR OF THE ENDOSCOPE AND THE OUTPUT CONNECTOR OF THE SUBJECT DEVICE DURING THE PROCEDURE. THOSE POSSIBILITIES MAY HAVE CAUSED THE PHENOMENON. THE CLV-S40PRO INSTRUCTION MANUAL ALREADY STATES; CONFIRM THAT THE ENDOSCOPE CONNECTOR IS CONNECTED TO THE OUTPUT SOCKET OF THE LIGHT SOURCE. IN CASE OF INSTRUMENT FAILURE OR MALFUNCTION, ALWAYS KEEP ANOTHER LIGHT SOURCE IN THE ROOM READY FOR USE. NEVER USE THE LIGHT SOURCE IF AN ABNORMALITY IS SUSPECTED. DAMAGE OR IRREGULARITY IN THE INSTRUMENT MAY COMPROMISE PATIENT OR USER SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. STORE THE EQUIPMENT AT ROOM TEMPERATURE IN THE HORIZONTAL POSITION IN A CLEAN, DRY AND STABLE LOCATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED ON DECEMBER 11, 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2014-00132 TO PROVIDE DEVICE EVALUATION RESULTS. OLYMPUS PERFORMED AN ADDITIONAL INVESTIGATION OF THE SUBJECT DEVICE. DURING A TEST IN A HIGH-TEMPERATURE ENVIRONMENT, THE EXAMINATION LAMP WENT OUT, THE BEEP WAS EMITTED, AND THE EMERGENCY LAMP LIT. THE THERMAL SWITCH ERROR WAS RECORDED IN ITS ERROR LOG. IN THE VIDEO IMAGE OF THE PROCEDURE, THERE WERE THE IMAGES IN WHICH THE EXAMINATION LAMP LOOKED LIKE GOING OFF AND THE EMERGENCY LAMP WAS SWITCHED TO ON. AS DESCRIBED IN THE INITIAL REPORT, DUST WAS FOUND IN THE VENTILATION GRILLS ON THE BOTTOM AND REAR PANELS OF THE SUBJECT DEVICE. BASED ON THE INVESTIGATION, THE TEMPERATURE IN THE SUBJECT DEVICE INCREASED BECAUSE OF THE DUST PREVENTING THE VENTILATION. THE SAFETY MECHANISM (THERMAL SWITCH) WAS ACTIVATED TO MAKE THE EXAMINATION LAMP GO OFF, AND THE EMERGENCY LAMP LIT ALTERNATIVELY. THE CLV-S40PRO INSTRUCTION MANUAL ALREADY STATES; -CONFIRM THAT THE VENTILATION GRILLS ON THE BOTTOM AND REAR PANELS OF THE LIGHT SOURCE ARE NOT COVERED WITH DUST OR OTHER MATERIALS. -CLEAN AND DUST THE VENTILATION GRILLS USING A VACUUM CLEANER. OTHERWISE, THE LIGHT SOURCE MAY BREAK DOWN AND GETS DAMAGED FROM OVER HEATING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE IMAGE OF THE ENDOSCOPE BECAME DARK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF ANOTHER SYSTEM. OLYMPUS SERVICE STAFF VISITED THE FACILITY AND INVESTIGATED THE VIDEO IMAGE OF THAT PROCEDURE IN WHICH THE IMAGE OF THE ENDOSCOPE WAS AS DARK AS THAT OF EMERGENCY LIGHT. BUT THE PHENOMENON WAS NOT REPRODUCED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198778 VISERA PRO XENON LIGHT SOURCE XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-S40PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK