BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 9449260 · Received December 11, 2019

    Report

    Report Number
    8010047-2019-04246
    Event Type
    Death
    Date Received
    December 11, 2019
    Date of Event
    October 31, 2019
    Report Date
    May 12, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, THEREFORE OMSC CANNOT INVESTIGATE THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS CLEANED USING AN UNSPECIFIED LOW TEMPERATURE STEAM AND FORMALDEHYDE (LTSF) MACHINE BEFORE RETURNED TO OLYMPUS EUROPA SE & CO. KG (OEKG) AND MICROBIOLOGICAL TESTING. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS EUROPA SE & CO. KG (OEKG) OEKG SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE DISTAL END, THE FORCEPS ELEVATOR, THE INSTRUMENT CHANNEL AND THE AIR/WATER CHANNELS OF THE DEVICE. AFTER THE ADDITIONAL MICROBIOLOGICAL TESTING, OEKG EVALUATED THE SUBJECT DEVICE AND CONFIRMED AS FOLLOWS; THE ADHESIVE AROUND THE OBJECT LENS AND THE LIGHT GUIDE LENS HAD WEAR. THERE WERE SCRATCHES ON THE DISTAL END COVER. THERE WAS CORROSION IN THE DISTAL END. THE ADHESIVE OF THE RUBBER OF THE BENDING SECTION HAD WEAR. DEBRIS WERE ON THE FORCEPS ELEVATOR. OEKG REVIEWED THE SERVICE HISTORY FOR THE SUBJECT DEVICE. OEKG CONFIRMED THAT THE DEVICE HAD NEVER BEEN REPAIRED BY OEKG BEFORE THIS EVENT OCCURRED. 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. 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 THAT A TOTAL OF THREE PATIENTS WERE INFECTED WITH KLEBSIELLA PNEUMONIAE RESISTANT TO MULTIPLE ANTIBIOTICS AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING THE SUBJECT DEVICE. THE PROCEDURE DATES OF THE THREE PATIENTS WERE AS FOLLOWS; FIRST PATIENT: (B)(6), 2019. SECOND PATIENT: (B)(6) 2019. THIRD PATIENT: (B)(6) 2019. IN THE THREE CASES, THE SAME BACTERIAL STRAIN WAS IDENTIFIED IN THE BLOOD. IT IS NOT SURE IF THE DEVICE IS CONTAMINATED AS THE DEVICE HAS NOT BEEN CULTURED. THE RELATIONSHIP BETWEEN THE INFECTION/DEATH AND THE SUBJECT DEVICE IS CURRENTLY UNKNOWN. THE SECOND PATIENT AND THE THIRD PATIENT WERE INFECTED WITH KLEBSIELLA PNEUMONIAE RESISTANT TO MULTIPLE ANTIBIOTICS AND PRODUCE OF CARBAPENEMASE. THE FIRST PATIENT AND THE SECOND PATIENT WERE DISCHARGED FROM THE USER FACILITY. THE THIRD PATIENT DIED ON (B)(6) 2019. THE USER FACILITY STATED THAT THEY CANNOT PROVIDE ANY FURTHER INFORMATION REGARDING THE PATIENTS. THE USER FACILITY DOESN'T HAVE A PLAN TO CULTURE THE DEVICE SINCE THEY ARE LOOKING FOR A LABORATORY IN PORTUGAL THAT CAN CULTURE DUODENOSCOPES IN ACCORDANCE WITH THE INTERNATIONAL GUIDELINES. THE DEVICE IS OUT OF SERVICE IN THE USER FACILITY. THE USER FACILITY HAD CLEANED/DISINFECTED THE SUBJECT DEVICE USING AN OLYMPUS CLEANING BRUSH (BW-412T AND MAJ-1888) AND OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, ONE MINI ETD2, TWO ETD2, AND TWO ETD4 (NOT AVAILABLE IN THE USA) WITH PERACETIC ACID. THE USER FACILITY OWNS OTHER OLYMPUS DEVICES INCLUDING ENDOSCOPES AND ENDOSCOPE PREPROCESSOR ETDS. NO INFECTION HAS BEEN REPORTED. RELATED TO THE OTHER DEVICES. OMSC IS SUBMITTING THREE MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF POTENTIALLY INFECTED PATIENTS. THIS IS 3 OF 3 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246431 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O