BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 12719180 · Received October 29, 2021

    Report

    Report Number
    8010047-2021-13817
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 30, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION AND THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) OBTAINED ADDITIONAL INFORMATION ABOUT THE 1ST PATIENT (M.M) FROM THE USER AS FOLLOWING. (B)(6), 2021; USES TJF-260V PATIENT: M.M DIAGNOSIS: COMMON BILE DUCT STONE PROGRESS: (B)(6) ; EMERGENCY HOSPITALIZATION FOR FEVER AND JAUNDICE. DIAGNOSED AS OBSTRUCTIVE JAUNDICE AND ACUTE CHOLANGITIS. EMERGENCY ERCP WAS PERFORMED AND ENDOSCOPIC STONE REMOVAL WAS PERFORMED (PSEUDOMONAS AERUGINOSA AND 2 OTHER STRAINS WERE DETECTED IN BILE CULTURE). (HEREAFTER, PSEUDOMONAS AERUGINOSA, WHICH DOES NOT HAVE A DESCRIPTION SUCH AS POT INSPECTION NOT PERFORMED, IS POT TYPE 307-0) (B)(6) ; HE HAD A FEVER OF 40 DEGREE (NEGATIVE BLOOD CULTURE) AND WAS TREATED WITH ANTIBACTERIAL DRUGS. (B)(6) ; ANTIPYRETIC (B)(6) ; DISCHARGED. AFTER THAT, THERE IS NO SUSPICION OF AN INFECTIOUS DISEASE. OMSC WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. [(B)(6), 2021] EXTERIOR (WITH DISTAL END CAP, DRY COTTON SWAB WIPE): GNC (+) EXTERIOR (WITH DISTAL END CAP, WET COTTON SWAB WIPE): GNC¿YEAST (+) DISTAL END (WITHOUT CAP, WASH): S. EPIDERMIDIS (+) DISTAL END CAP (SHAKE): S. EPIDERMIDIS (+) FORCEPS ELEVATOR (OUTER WIPE): S. EPIDERMIDIS (1+) SUCTION CHANNEL: C. GLABRATA (1+) [(B)(6), 2021] AIR/WATER VALVE: GPR (+) AIR CHANNEL: GPR (+) DISTAL END CAP (SONICATION): BACILLUS (+) SUCTION CHANNEL: E. FAECIUM, C. GLABRATA (+) [(B)(6), 2021] SUCTION CHANNEL: E. FAECIUM, C. GLABRATA (+) LIQUID SPILLED ON THE WORKBENCH DURING RECOVERY AFTER REMOVAL OF THE STENT: S. CAPITIS, E.FAECIUM, C. GLABRATA (+) BRUSH INSERTION: E.FAECIUM, C. GLABRATA (+) LIQUID LEAKED FROM THE WATER CHANNEL: P. AERUGINIOSA (1+), E. FAECIUM (+) POT NUMBER 307-0 COLLECT AFTER REMOVING THE BRUSH (INSTRUMENT CHANNEL PORT): E.FAECIUM, C. GLABRATA (1+) DISTAL END (SONICATION): C. GLABRATA (1+), B. CEREUS (+) BRUSH BODY: ALPHA-STREPTOCOCCUS (1+), S. AUREUS (+), CNS (+), C. GLABRATA (+) THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-3/4, USING PERACETIC ACID. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM THE USER, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE CLEANING, DISINFECTION AND STERILIZATION (CDS) WAS INSUFFICIENT AND/OR INAPPROPRIATE.

    Additional Manufacturer Narrative · 0

    THERE IS MORE INFORMATION ON THE DEVICE EVALUATION. CORRECTION IS BEING MADE FOR INFORMATION NOT INCLUDED IN THE SUBMITTED MDRS (CUSTOMER REPROCESSING INFORMATION, B6, E1, G2, H6). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. REPROCESSING INFORMATION OF THE FACILITY: · AIR/WATER (AW) CHANNEL CLEANING ADAPTER IS NOT USED. · IT IS UNKNOWN WHETHER THE BIOPSY CHANNEL WAS BRUSHED. · IT IS UNKNOWN WHETHER THE SUCTION CHANNEL WAS BRUSHED. · IT IS UNKNOWN WHETHER THE BIOPSY PORT WAS BRUSHED. · IT IS UNKNOWN WHETHER THE FORCEPS ELEVATOR WAS BRUSHED. · THE REPROCESSORS USED ARE OER-3 AND OER-4, BUT THE SERIAL NUMBER AND THE DATE WHEN THE DISINFECTANT WAS LAST REPLACED ARE UNKNOWN. BASED ON THE FOLLOWING INVESTIGATION RESULTS, IT IS MOST LIKELY THAT THIS DEVICE WAS RELATED TO THE INFECTION OF THE PATIENT. PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0" WAS DETECTED IN BILE CULTURES AND/OR BLOOD CULTURES OF THE PATIENT. AS A RESULT OF THE THIRD CULTURE TEST OF THE DEVICE AT THE FACILITY, PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0" WAS OBTAINED FROM THE SAMPLING SOLUTION OF THE AIR SUPPLY/WATER SUPPLY CHANNEL. OF THE TOTAL OF THREE CULTURE TESTS CONDUCTED AT THE FACILITY, C. GLABRATA WAS DETECTED IN THE SUCTION TUBE IN ALL THE RESULTS, AND E. FAECIUM WAS DETECTED IN THE SUCTION TUBE IN THE RESULTS OF THE SECOND AND THIRD CULTURE TESTS. FROM THE CONFIRMATION RESULTS OF THE REPROCESS PROCEDURE AT THE FACILITY, IT WAS CONFIRMED THAT THERE WAS A CLEAR DEVIATION FROM IFU THAT THE AIR/WATER SUPPLY CHANNEL CLEANING ADAPTER WAS NOT USED FOR CLEANING THE AW CHANNEL. BASED ON THE INVESTIGATION RESULTS, REGARDING THE POSITIVE CULTURE RESULTS OF THE DEVICE IT IS MOST LIKELY THAT THE REPROCESSING OF THE DEVICE WAS INSUFFICIENT. SINCE THE PRODUCT WAS NOT RETURNED, VISUAL CONFIRMATION AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE SUBJECT DEVICE. 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 FROM PHARMACEUTICALS AND MEDICAL DEVICES AGENCY WITH THE REPORT FROM THE USER, IT WAS FOUND THAT PSEUDOMONAS AERUGINOSA SIMILAR TO THAT OF THE PREVIOUS PROCEDURE WAS DETECTED IN 4 PATIENTS WHO WERE USED THE SUBJECT DEVICE. THE DETAILS OF THE PROCESS ARE AS FOLLOWS. ON (B)(6) 2021 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND BILE DUCT STONE REMOVAL WERE PERFORMED USING THE SUBJECT DEVICE, AND BILE CULTURE WAS PERFORMED AT THAT TIME. AFTER THAT, PSEUDOMONAS AERUGINOSA, KLEBSIELLA, CITROBACTER-POSITIVE WITH POT NUMBER "307-0". ON (B)(6) 2021 THIS PATIENT WAS RECOVERED AND DISCHARGED. ON (B)(6) 2021 THERE IS A REPORT OF DETECTION OF PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0". THE USER FACILITY THOUGHT IT WAS ALREADY OWNED BY THE PATIENT. ON (B)(6) 2021: SINCE (B)(6) 2021, PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0" WAS DETECTED IN BILE OR BLOOD SAMPLES OF 4 PATIENTS WHO UNDERWENT ERCP USING THE SUBJECT DEVICE. ON (B)(6) 2021. THE SAME POT-TYPE PSEUDOMONAS AERUGINOSA WAS DETECTED FROM THE SUBJECT DEVICE. THE USER COMPLETED THE INTENDED PROCEDURE WITH THE SUBJECT DEVICE. THE DEVICE HAD BEEN REPROCESSED USING WEAKLY ALKALINE CLEANING SOLUTION. CURRENTLY THE USER DOES NOT USE THE SUBJECT DEVICE. THE USER REPORTED THIS EVENT TO A LOCAL (KOBE CITY) PUBLIC HEALTH CENTER. OMSC IS SUBMITTING THIS MDR ACCORDING TO THE NUMBER OF THE PATIENTS, AND THIS REPORT IS 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622523 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male