BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 12414072 · Received September 2, 2021

    Report

    Report Number
    8010047-2021-11147
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 4, 2021
    Report Date
    October 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E2, E3 ¿ REPEATED ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER, INCLUDING OCCUPATION, BUT WERE NOT SUCCESSFUL. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE DEVICE HISTORY RECORD (DHR) REVIEW. THE REVIEW OF THE DHR DID NOT FIND ANY ABNORMALITIES OR ANOMALIES IDENTIFIED DURING PRODUCTION. THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE. THE EXACT CAUSE OF THE CUSTOMER¿S ALLEGATION COULD NOT BE DETERMINED. THE SUBJECT DEVICE WAS NOT RETURNED. THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR MAY HAVE BEEN WET OR HAD RESIDUE WHEN CONNECTED TO THE SUBJECT DEVICE. THIS MAY HAVE CAUSED THE ELECTRICAL CONTACTS TO BECOME UNSTABLE, PREVENTING THE COMMUNICATION BETWEEN THE SCOPE AND VIDEO PROCESSOR, CAUSING THE B30 ERROR. THE CONNECTION OF THE DIGITAL LIGHT SOURCE MAY ALSO NOT HAVE BEEN APPROPRIATE, PREVENTING THE COMMUNICATION BETWEEN THE SCOPE AND VIDEO PROCESSOR, CAUSING THE B30 ERROR. THE INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING: ¿MAKE SURE THAT THE VIDEO CONNECTOR AND ITS ELECTRICAL CONTACTS ARE COMPLETELY DRY BEFORE CONNECTING THE PLUG TO THE VIDEO SYSTEM CENTER. IF THEY ARE WET, WIPE THEM ACCORDING TO THE INSTRUCTION MANUAL FOR THE ENDOSCOPE. WET EQUIPMENT COULD CAUSE THE IMAGE TO FLICKER OR DISAPPEAR.¿ ¿PROPERLY AND SECURELY CONNECT ALL CABLES. IF THE CABLE CONNECTOR HAS CONNECTION SCREWS, TIGHTEN UP THE SCREWS. OTHERWISE, EQUIPMENT DAMAGE OR MALFUNCTION CAN RESULT.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) VIA THE PHONE, THE USER HAD REPORTED A B30 ERROR WHEN EXIS EXERA III XENON LIGHT SOURCE WAS CONNECTED TO THE 190 MODEL TYPE SCOPE SERIES. THE USER WAS INFORMED THERE COULD BE DEBRIS PRESENT ON THE ELECTRICAL CONTACTS OF THE SCOPES. THE USER WAS INSTRUCTED TO WIPE THE ELECTRICAL CONTACTS ON THE ENDOSCOPE CONNECTOR USING CLEAN LINT FREE CLOTHS MOISTENED WITH 70% ETHYL OR 70% ISOPROPYL ALCOHOL. THE USER WAS THEN INSTRUCTED TO RECONNECT THE ENDOSCOPE TO THE LIGHT SOURCE AFTER ENSURING THE ELECTRICAL CONTACTS WERE DRY. ACCORDING TO THE USER, THESE TROUBLESHOOTING STEPS WERE PERFORMED MULTIPLE TIMES WITHOUT RESOLVING THE ERROR. THE USER WAS INSTRUCTED THE ERROR WOULD NEED TO BE CLEARED PRIOR TO ATTEMPTING TO INSTALL A SCOPE TO THE LIGHT SOURCE. UPON REPLACING THE SUBJECT DEVICE WITH A SIMILAR ONE, THERE WAS A SCOPE IMAGE AND THERE WERE NO ERRORS PRESENT. THE USER INFORMED TAC, THE SUBJECT DEVICE WOULD BE RETURNED FOR EVALUATION UPON FOLLOW UP WITH THE USER FACILITY, OLYMPUS WAS INFORMED THE DEVICE WOULD NOT BE RETURNED AS THE ISSUE HAD BEEN RESOLVED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE RESOLUTION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. 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 · 1

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), A B30 ERROR WAS OBSERVED ON THE EXIS EXERA III XENON LIGHT SOURCE PRIOR TO AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315046 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 190 MODEL SCOPE SERIESMODEL UNKNOWN| MAJ- 1941| MAJ-1933