BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 15872983 · Received November 28, 2022

    Report

    Report Number
    3002808148-2022-04632
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 2, 2022
    Report Date
    December 23, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE PHENOMENON, "B30 ERROR OCCURRED", WAS NOT REPRODUCED AS THE PRODUCT WAS NOT RETURNED. HOWEVER, A PROBABLE CAUSE WAS DETERMINED TO BE DUE TO AN ABNORMALITY IN COMMUNICATION WITH THE SCOPE RESULTING FROM FOREIGN MATTER ADHERING TO THE ELECTRICAL CONTACT PART OR MOISTURE ADHESION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ACCORDING TO THE SERVICE MANUAL, B30 ERROR INDICATES SCOPE COMMUNICATION ERROR, AND IT IS A MESSAGE THAT IS DISPLAYED WHEN THE DEVICE FAILS TO LOAD SCOPE ID DATA TO HARDWARE (REGISTRY ERROR OCCURS). MAINLY, IT OCCURS WHEN A FOREIGN MATERIAL OR MOISTURE IS ADHERED TO THE ELECTRICAL CONTACTS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE OLYMPUS ACCOUNT MANAGER (OAM) WAS PROVIDED A REFERENCE GUIDE FOR MANAGING THE B30 ERROR. OAM LATER REPORTED THAT WHILE ON-SITE AT THE USER FACILITY, HE WAS NOT ABLE TO DUPLICATE THE ERROR. THE DEVICE IS NOT EXPECTED TO BE RETURNED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE OLYMPUS ACCOUNT MANAGER REPORTED (ON BEHALF OF THE CUSTOMER) THAT A B30 ERROR OCCURRED WHILE USING THE EVIS EXERA III VIDEO SYSTEM CENTER. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THERE WAS A ONE HOUR DELAY, PATIENT WAS NOT YET UNDER SEDATION AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677238 EVIS EXERA III VIDEO SYSTEM CENTER ENDOSCOPIC VIDEO IMAGE PROCESSING UNIT NWB SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown