BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 11691580 · Received April 20, 2021

    Report

    Report Number
    8010047-2021-05124
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE SCOPE COMMUNICATION ERROR B30 OCCURS WHEN COMMUNICATION FOR TRANSMITTING THE DATA OF THE ENDOSCOPE TO THE VIDEO SYSTEM CENTER COULD NOT BE COMPLETED SUCCESSFULLY. ACCORDING TO THE DEVICE INSPECTION RESULT BY OLYMPUS MEDICAL SYSTEMS VIETNAM CO., LTD. (OVN), CORROSION OF CONTACT PINS OF THE VIDEO CONNECTOR SOCKET WAS CONFIRMED. THE PINS MAY HAVE CORRODED DUE TO THE USER CONNECTING THE ENDOSCOPE WHILE IT IS STILL WET, OR NOT CLEANING THE WATER DROPLETS OR DIRT ADHERING TO THE ELECTRICAL CONTACTS OF THE ENDOSCOPE. THIS COULD HAVE BLOCKED COMMUNICATION AND RESULTED IN THE ERROR B30. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. 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 · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; THE REPORTED PHENOMENON WAS NOT REPRODUCED. THE LOCKING LEVER OF THE VIDEO CONNECTOR SOCKET WAS DAMAGED. THE CONTACT PIN OF THE VIDEO CONNECTOR SOCKET WAS CORRODED. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE ENDOSCOPIC PROCEDURE, THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED ON THE MONITOR. AFTER THAT, THE ERROR CODE B30 DISAPPEARED FROM THE SCREEN, AND THE DOCTOR CONTINUED THE PROCEDURE. AFTER A FEW MINUTES, THE ERROR CODE B30 REAPPEARED ON THE SCREEN AND THEN DISAPPEARED. THE DEVICE WAS USED WITH THE OLYMPUS LIGHT SOURCE CLV-190 AND THE FLEX VIDEO SCOPE GIF-H170. THE DOCTOR STOPPED THE PROCEDURE, AFTER WHICH THE DOCTOR COMPLETED THE PROCEDURE WITH ANOTHER OLYMPUS 190 SERIES SYSTEMS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591572 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1