BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 13081857 · Received December 23, 2021

    Report

    Report Number
    8010047-2021-16768
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    December 6, 2021
    Report Date
    April 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K202661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION (ALTHOUGH IT IS ANTICIPATED). THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED PLEASE REFERENCE B5 AND D4 FOR DETAILS. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO DEFECTS WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A FEW DEFECTS WERE NOTED INCLUDING WHERE THE BENDING SECTION RUBBER GLUE WAS CRACKED AND THERE WAS FAILURE IN THE WATER FLOW TESTING. IT WAS ALSO NOTED THAT THERE WAS NO ABNORMAL APPEARANCE IN THE DISTAL END COVER OF THE DEVICE. A DEVICE FROM A SIMILAR LOT (H1412) WAS TESTED WHERE IT WAS ATTEMPTED TO REPLICATE THE REPORTED FAILURE USING A DISTAL COVER. IT WAS CONFIRMED THAT THE DISTAL COVER WILL NEVER COME OFF WHEN IT HAS NO DAMAGE AND IT IS CORRECTLY ATTACHED TO THE SCOPE. 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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. HOWEVER THE FOLLOWING SCENARIO LIKELY CAUSED THE EVENT: I) THE COVER BECAME SLIGHTLY TORN BY IMPROPER ATTACHMENT STEPS TO THE SCOPE. (EX. THE COVER WAS PUSHED DIAGONALLY.) OR, THE COVER WAS IN FRAGILE CONDITION BECAUSE IT HAD SLIGHTLY CRUSHED BEFORE ATTACHED TO THE SCOPE. II) THE COVER WAS DAMAGED FURTHER BY STRESS FROM BEING ATTACHED TO THE SCOPE OR BEING USED FOR PROCEDURE (FRICTION STRESS BY TWISTED/PUSHED/PULLED IN THE PATIENT BODY). THE FOLLOWING IS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE (IFU) AND MAY HELP DETECT / PREVENT THE EVENT: "INSPECTION OF ACCESSORIES: INSPECTION OF THE SINGLE USE DISTAL COVER (MAJ-2315) SHOULD ANY IRREGULARITY BE OBSERVED WHEN INSPECTING THE SINGLE USE DISTAL COVER, DO NOT USE IT. A SINGLE USE DISTAL COVER WITH IRREGULARITY COULD NOT SERVE THE ENDOSCOPE PROPERLY AND/OR COULD FALL OFF DURING THE EXAMINATION." "ATTACHING ACCESSORIES TO THE ENDOSCOPE: ATTACHING THE SINGLE USE DISTAL COVER NEVER USE THE ENDOSCOPE UNLESS THE SINGLE USE DISTAL COVER IS PROPERLY ATTACHED TO THE DISTAL END. IF THE SINGLE USE DISTAL COVER IS NOT ATTACHED PROPERLY, IT MAY SLIP OFF OR FALL OFF THE DISTAL END DURING THE EXAMINATION. -WHEN THE ENDOSCOPE IS REPEATEDLY INSERTED INTO THE BODY CAVITY, ALWAYS CONFIRM THAT THE SINGLE USE DISTAL COVER IS ATTACHED PROPERLY BEFORE INSERTION. IF THE SINGLE USE DISTAL COVER IS NOT ATTACHED PROPERLY, IT MAY SLIP OFF OR FALL OFF THE DISTAL END DURING THE EXAMINATION. - NEVER USE A SINGLE USE DISTAL COVER WITH CRACKS OR PINHOLES. REPLACE IT WITH A NEW ONE. IF A SINGLE USE DISTAL COVER WITH CRACKS OR PINHOLES IS USED, IT COULD FALL OFF DURING THE EXAMINATION AND/OR, IT MAY CAUSE THERMAL INJURY DUE TO ELECTRIC CURRENT LEAKS FROM CRACKS OR PINHOLES WHEN HIGH-FREQUENCY CAUTERIZATION TREATMENT IS PERFORMED. - DO NOT APPLY ANTI-FOGGING PRODUCTS, OLIVE OIL, OR PRODUCTS CONTAINING PETROLEUM-BASED SUBSTANCES (E.G., VASELINE®) TO THE SINGLE USE DISTAL COVER AND THE ENDOSCOPE. THESE PRODUCTS MAY CAUSE CRACKS OF THE SINGLE USE DISTAL COVER.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING A EVIS EXERA III DUODENOVIDEOSCOPE WITH A MAJ-2315 SINGLE USE DISTAL COVER, THE DISTAL COVER SPLIT OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE ONE HALF OF THE DISTAL COVER. THE OTHER HALF REMAINS INSIDE THE PATIENT¿S GASTROINTESTINAL (GI) TRACT. THERE IS NO PLAN TO GO BACK IN AND RETRIEVE THE SECOND HALF OF THE DISTAL COVER, THE PHYSICIAN FEELS IT WILL PASS NATURALLY THROUGH THE PATIENT¿S GI TACT WITH NO FURTHER CONSEQUENCES. THE PATIENT¿S CURRENT CONDITION IS DESCRIBED AS ¿FEELING BETTER¿. THERE WERE NO PROCEDURAL OR ANATOMICAL CHALLENGES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO ABNORMALITY IN THE APPEARANCE OF THE SCOPE OR CAP PRIOR TO THE START OF THE PROCEDURE. CASE WITH PATIENT (B)(6) REPORTS THE MAJ-2315 USED IN THE PROCEDURE. CASE WITH PATIENT (B)(6) REPORTS THE TJF-Q190V USED IN THE PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER. IT IS UNKNOWN WHETHER ANTI-FOG AGENTS OR OTHER CHEMICALS ARE USED. IT HAS BEEN CONFIRMED THAT THE COVER IS NOT CRACKED IMMEDIATELY AFTER BEING ATTACHED TO THE SCOPE AND THAT THE COVER DOES NOT COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973853 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q190V H0929 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male MAJ-2315, LOT H0929