BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 12257397 · Received August 1, 2021

    Report

    Report Number
    8010047-2021-09597
    Event Type
    Malfunction
    Date Received
    August 1, 2021
    Date of Event
    July 5, 2021
    Report Date
    September 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE FAILURE OF THE PATIENT BOARD WAS CONFIRMED FROM THE DEVICE INSPECTION RESULT, IT IS POSSIBLE THAT THE SCOPE COMMUNICATION ERROR B30 AND THE COLOR BAR WERE DISPLAYED DUE TO THE COMMUNICATION ERROR WITH THE ENDOSCOPE CAUSED BY THE FAILURE OF THE BOARD. SINCE THERE WAS NO EVIDENCE OF DAMAGE TO THE PATIENT BOARD, THE BOARD FAILURE MAY HAVE BEEN CAUSED BY THE FOLLOWING: -ACCIDENTAL FAILURE -DETERIORATION DUE TO REPEATED USE AS FIVE YEARS HAVE PASSED SINCE THE DEVICE WAS MANUFACTURED. THE INSTRUCTION MANUAL CONTAINS NOTES ON THE CABLE CONNECTION AND ENDOSCOPE CONNECTOR. BY FOLLOWING THIS INSTRUCTION, THE USER MAY BE ABLE TO PREVENT THE OCCURRENCE OF SCOPE COMMUNICATION ERROR B30. 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 DEVICE WAS EVALUATED AT OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI). AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. -THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED ON THE MONITOR DUE TO A PATIENT BOARD SET FAILURE. THERE WERE NO BURN MARKS OR PARTS ON THIS BOARD. THIS FAILURE MODE IS A MDR REPORTABLE MALFUNCTION. -THE VIDEO CONNECTOR SOCKET WAS LOOSE. THIS CAN CAUSE FLICKERING OF THE ENDOSCOPIC IMAGE. THE VIDEO CONNECTOR SOCKET MAY HAVE COME LOOSE DUE TO HEAVY PRESSURE. -THERE WERE MULTIPLE CRACKS IN THE FRONT PANEL. THE SCREW COULD NOT BE FIXED WITH THE PROPER TORQUE. IT IS POSSIBLE THAT A HARD OBJECT HIT IT AND CAUSED A CRACK. -THE PHENOMENON REPORTED BY THE USER WAS NOT REPRODUCED. 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

    THE DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS MEDICAL SYSTEMS (B)(4) BUT HAS NOT BEEN RETURNED YET. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, 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 FOR USE, THE COLOR BAR WAS DISPLAYED INSTEAD OF THE ENDOSCOPIC IMAGE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154369 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1