BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 11963253 · Received June 8, 2021

    Report

    Report Number
    8010047-2021-07272
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 7, 2021
    Report Date
    December 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K202646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: -THERE WERE NO ABNORMALITIES IN THE VISUALLY RECOGNIZABLE PART OF THE APPEARANCE OF THE DEVICE. -IT WAS CONFIRMED USING THE CAMERA HEAD AND INFRARED LIGHT SOURCE OF OLYMPUS ASSETS WHETHER THE PHENOMENON REPORTED BY THE USER WAS REPRODUCED. USING THE CAMERA HEAD OF OLYMPUS ASSET, THE DEVICE WAS OPERATED FOR ABOUT 30 MINUTES, BUT NO BLACKOUT OF THE ENDOSCOPIC IMAGE WAS CONFIRMED. IN ADDITION, THE PHENOMENON THAT THE WHITE LIGHT TURNED GREEN WAS NOT CONFIRMED. ALSO, NO HALATION IN THE IMAGE WAS CONFIRMED WHEN SWITCHING TO INFRARED. AT THE TIME OF CONFIRMATION USING INFRARED, THE DEVICE WAS COMPARED WITH THE VIDEO SYSTEM CENTER OTV-S300 OF AN OLYMPUS ASSET, BUT THE REPORTED PHENOMENON COULD NOT BE CONFIRMED. -WHEN THE DEVICE WAS CONNECTED AND OPERATED ACCORDING TO THE INSTRUCTION MANUAL, THERE WAS NO ABNORMALITY. THE USER FACILITY REPORTED THAT THE DEVICE HAD BEEN WIPED CLEAN WITH ALCOHOL. ALSO, A SIMILAR EVENT HAD OCCURRED AT THE USER FACILITY IN THE PAST BUT WAS NOT RETURNED TO OMSC. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE REPORTED EVENT THAT THE ENDOSCOPE WENT BLACK OCCURRED ON (B)(6) 2021 AND WAS ALREADY REPORTED IN MFR REPORT # 8010047-2021-04718. OMSC CHECKED THE DEVICE ACTIVITY LOG FOR (B)(6) 2021 AND FOUND NO SPECIFIC ERRORS. IN ADDITION, OMSC CONFIRMED THAT THE REPORTED EVENT WAS NOT REPRODUCED DURING NORMAL TIMES OR UNDER HEAVY LOAD WITH THE DEVICE RUNNING CONTINUOUSLY FOR MORE THAN 4 HOURS. SINCE THERE WAS NO ABNORMALITY IN THE DEVICE, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY SOMETHING WRONG WITH THE DEVICE USED IN COMBINATION WITH THE DEVICE AT THE USER FACILITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE REPORTED EVENT WAS NOT REPRODUCED. THE REPORTED EVENT DID NOT OCCUR DUE TO PRODUCT OR MANUFACTURING, AND OMSC CONFIRMED THAT THERE ARE NO ISSUES WITH DEVICE SAFETY. ALSO, THE REPORTED EVENT DOES NOT TEND TO OCCUR FREQUENTLY. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE DEVICE AGAIN FOR INSPECTION IN COMBINATION WITH THE CAMERA HEAD THAT WAS USED IN COMBINATION WITH THE DEVICE AT THE USER FACILITY. OMSC CONFIRMED THE FOLLOWING. -AS A RESULT OF THE DEVICE COMBINATION INSPECTION, THE PHENOMENON THAT THE ENDOSCOPIC IMAGE BECAME BLACK DID NOT OCCUR. -THERE WAS NO EVIDENCE OF CHEMICAL STICKING OR DAMAGE TO THE VIDEO CONNECTOR SOCKET OF THE DEVICE. -THERE WAS A WATER DROP MARK ON THE VIDEO CONNECTOR OF THE CAMERA HEAD OWNED BY THE USER FACILITY. -THERE WERE NO ABNORMALITIES IN OTHER PARTS OF THE DEVICE. BASED ON THE ABOVE, OMSC DETERMINED THAT THERE WAS NO ABNORMALITY IN THE DEVICE. IN ADDITION, OMSC CONFIRMED THE FOLLOWING: NO HALATION OR IMAGE ABNORMALITIES OCCURRED IN THE ENDOSCOPIC IMAGE. WHEN THE WHITE BALANCE WAS ADJUSTED, NO ERROR OCCURRED, BUT THE MONITOR SCREEN TURNED RED FOR A MOMENT. OMSC CHECKED THE DEVICE ACTIVITY LOGS AND FOUND NO SPECIFIC ERRORS. THE PHENOMENON THAT THE ENDOSCOPIC IMAGE TURNED GREEN DID NOT OCCUR. FROM THE ABOVE, OMSC SURMISED THAT THERE WAS A POSSIBILITY OF SOME KIND OF MALFUNCTION IN BOTH THE CONTROL BOARD AND THE IMAGE BOARD. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. IN ADDITION, IT STATES HOW TO IDENTIFY THE ABNORMALITY AND HOW TO DEAL WITH IT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE PREPARATION BEFORE THE PROCEDURE FOR TREATMENT, THE ENDOSCOPIC IMAGE BECAME BLACK. IN ADDITION, HALATION OCCURRED IN THE ENDOSCOPIC IMAGE DURING INFRARED OBSERVATION, AND THE ENDOSCOPIC IMAGE BECAME GREEN DURING INSPECTION USING WHITE LIGHT. THE DEVICE WAS USED WITH AN OLYMPUS CAMERA HEAD CH-S200-XZ-EA, AN OLYMPUS FLEX VIDEOSCOPE LTF-S190-10, A SONY MONITOR LMD-X310ST, OLYMPUS RIGID ENDOSCOPE WAIR100A AND WAIR130A. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850701 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown