BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 15800494 · Received November 15, 2022

    Report

    Report Number
    3002808148-2022-04195
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 21, 2022
    Report Date
    December 21, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170386077
    PMA / PMN Number
    K202646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE OLYMPUS ACCOUNT MANAGER (OAM) REPORTED (ON BEHALF OF THE CUSTOMER) THERE WAS AN E226 SCOPE COMMUNICATION ERROR WHILE USING THE VISERA ELITE II VIDEO SYSTEM CENTER. THE OAM STATED THE ISSUE OCCURS ANY TIME A SCOPE IS CONNECTED TO THE DEVICE, AND THAT THE SCOPES WORK ON OTHER TOWERS. TAC INSTRUCTED OAM TO HAVE THE CUSTOMER CLEAN THE CONTACTS WITH 70% ETHYL OR ISOPROPYL ALCOHOL WITH A LINT FREE CLOTH AND CONNECT THE SCOPES AGAIN. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE, AND THE OAM AGREED TO HAVE THE CUSTOMER SEND IN THE DEVICE FOR EVALUATION AND REPAIR. THE CUSTOMER LATER REPORTED THAT AFTER CLEANING THE MACHINE, THE DEVICE IS WORKING PROPERLY AND THE ISSUE IS CONSIDERED RESOLVED. THE DEVICE IS NOT EXPECTED TO BE RETURNED. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED, THE PHENOMENON COULD NOT BE REPRODUCED. AS A RESULT, THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE INSTRUCTION MANUAL OF OTV-S300 DESCRIBES THE FOLLOWING, AND THE REPORTED PHENOMENON MIGHT HAVE BEEN PREVENTED BY FOLLOWING THE DESCRIPTIONS. [5.3 CONNECTION OF AN ENDOSCOPE] "MAKE SURE THAT THE VIDEO CONNECTOR AND ITS ELECTRICAL CONTACTS ARE COMPLETELY DRY AND FOREIGN OBJECTS SUCH AS DETERGENT REMNANTS, HARD WATER RESIDUE, FINGER GREASE, DUST, AND LINT ARE NOT ON THE ELECTRICAL CONTACTS. IF THE ENDOSCOPE IS USED WITH WET AND/OR DIRTY ELECTRICAL CONTACTS, THE ENDOSCOPE AND VIDEO SYSTEM CENTER MAY MALFUNCTION." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS ACCOUNT MANAGER REPORTED (ON BEHALF OF THE CUSTOMER) THAT THERE WAS AN E226 SCOPE COMMUNICATION ERROR WHILE USING THE VISERA ELITE II VIDEO SYSTEM CENTER. THE PROCEDURE INVOLVED WAS THERAPEUTIC, AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773371 VISERA ELITE II VIDEO SYSTEM CENTER ENDOSCOPIC VIDEO IMAGE PROCESSING/LIGHT SOURCE SYSTEM FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S300 04953170386077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SCOPE.