BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11683443 · Received April 18, 2021

    Report

    Report Number
    8010047-2021-05063
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Report Date
    April 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170229503
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON APRIL 7, OMSC RECEIVED THE LITERATURE "NATIONWIDE PREVALENCE OF BACTERIAL CONTAMINATION OF DUODENOSCOPES AND LINEAR ECHOENDOSCOPES IS PERSISTENTLY HIGH IN THE NETHERLANDS: THE PROCESS 2 STUDY. ". THE PURPOSE OF THE LITERATURE WAS TO DETERMINE THE PREVALENCE OF BACTERIAL CONTAMINATION OF ALL REPROCESSED DUODENOSCOPES AND LINEAR ECHOENDOSCOPES (DLES) IN THE NETHERLANDS. ALL 75 DUTCH ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)/ ENDOSCOPIC ULTRASOUND (EUS) CENTRES WERE INVITED TO SAMPLE ALL DLES USING CENTRALLY DISTRIBUTED KITS, ACCORDING TO UNIFORM SAMPLING METHODS EXPLAINED BY VIDEO INSTRUCTIONS. LOCAL STAFF SAMPLED FOUR TO SIX SITES PER DLE DEPENDING ON ENDOSCOPE TYPE, INCLUDING SWABS (PROTECTION CAP, FORCEPS ELEVATOR), FLUSHES (BIOPSY, SUCTION, AIR/WATER AND FORCEPS ELEVATOR CHANNEL) AND BRUSHES (BIOPSY, AIR/WATER AND BALLOON CHANNEL). BETWEEN OCTOBER 2016 AND APRIL 2017, 62 (85%) DUTCH ERCP/EUS CENTRES RESPONDED WITH 1130 SAMPLES OF 215 DLES (158 DUODENOSCOPES AND 57 LES). FIFTEEN DIFFERENT DLE TYPES FROM THREE DISTINCT MANUFACTURERS WERE SAMPLED. THE LITERATURE WROTE AS BELOW. ¿IN TOTAL 29/62 (47%) CENTRES HAD AT LEAST ONE AM20 OR MGO CONTAMINATED DLE, SIMILAR TO THE PREVALENCE (31/66 CENTRES; 47%) IN OUR PREVIOUS STUDY (PZ0.98). TWENTY-EIGHT (13%) DLES FROM 19 (31%) CENTRES WERE AM20 CONTAMINATED. THIRTY-TWO (15%) DLES FROM 23 (37%) CENTRES WERE CONTAMINATED WITH MGO, INCLUDING ENTEROBACTERIACEAE, PSEUDOMONAS AERUGINOSA AND CANDIDA SPP. AM20 CONTAMINATION WAS IDENTIFIED IN EIGHT DIFFERENT DLE TYPES, MGO CONTAMINATION IN ALL NINE DUODENOSCOPE TYPES AND THREE LE TYPES.¿ BASED ON THE AVAILABLE INFORMATION, THE OLYMPUS PRODUCT WAS NOT WRITTEN IN THE LITERATURE. HOWEVER, SOME OF THE USED ENDOSCOPE MIGHT BE OLYMPUS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580746 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170229503

    Patients

    Seq Age Sex Outcome Treatment
    1