BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8825521 · Received July 25, 2019

    Report

    Report Number
    8010047-2019-02703
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    September 13, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170229503
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS EUROPA HOLDING GMBH (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, THE AIR/WATER CHANNEL AND THE AUXILIARY WATER CHANNEL OF THE DEVICE. AFTER THE MICROBIOLOGICAL TESTING, THE EVALUATION OF THE SUBJECT DEVICE BY OEKG CONFIRMED FOLLOWING DEFECTS. - CRACKED LIGHT GUIDE LENS. - SCRATCHED CCD LENS. - BUCKLED AND KINKED BENDING SECTION. - THE SUBJECT DEVICE HAD BEEN REPAIRED BY A THIRD PARTY REPAIR ENTITY. 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 CORRECTION AND ADDITIONAL INFORMATION. CORRECTED POINT IS "D4" OF THE INITIAL REPORT. THE MODEL NUMBER OF THE SUBJECT DEVICE WAS TJF-160VR, NOT TJF-Q180V. THE SERIAL NUMBER OF THE SUBJECT DEVICE WAS 2600890, NOT 2304154. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, MEDIVATOR, USING PERACETIC ACID. 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 OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. 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 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 THREE PATIENTS WERE INFECTED WITH MULTIDRUG-RESISTANT KLEBSIELLA PNEUMONIA AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN REPAIRED BY A THIRD PARTY REPAIR ENTITY. THE SUBJECT DEVICE TESTED NEGATIVE FOR KLEBSIELLA PNEUMONIA IN MICROBIOLOGICAL TESTING BY THE USER FACILITY. OMSC IS SUBMITTING THREE MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE INFECTED PATIENTS. THIS IS THREE OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619244 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VR 04953170229503

    Patients

    Seq Age Sex Outcome Treatment
    1