BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 9333953 · Received November 18, 2019

    Report

    Report Number
    8010047-2019-04012
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 8, 2019
    Report Date
    March 16, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. NO BLOOD TEST RESULTS ON THE PATIENTS WERE PROVIDED TO OLYMPUS. OLYMPUS VIETNAM CO., LTD.(OVN) CONTACTED THE USER FACILITY AND WAS INFORMED THAT THE FACILITY WOULD NOT DISCLOSE ANY FURTHER INFORMATION. OVN EVALUATED THE DEVICE ON NOVEMBER 13TH AND 14TH AND THE DEVICE PASSED ALL FUNCTIONAL TESTS. THE SUBJECT DEVICE IS QUARANTINED IN OVN. THE SUBJECT DEVICE WAS LOANED TO ANOTHER USER FACILITY AFTER THE INCIDENTS OCCURRED. THIS FACILITY USED THE TJF-Q180V FOR 2 PATIENTS. THERE WAS NO REPORT OF PATIENT INFECTION. 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 IN THIS REPORT WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC EVALUATED THE SUBJECT DEVICE AND CONFIRMED AS FOLLOWS; THERE WAS NO PHYSICAL FAILURE SUCH AS DEFORMATION, DAMAGE, SCRATCH, OR PINHOLE ON THE SUBJECT DEVICE. THERE WAS A RESIDUE ON THE DISTAL END OF THE SUBJECT DEVICE. THERE WAS A DIRT IN THE INNER OF THE INSTRUMENT CHANNEL AT 20 MM FROM THE DISTAL END. THERE WAS A CORROSION IN THE SUCTION CONNECTOR OF THE ENDOSCOPE CONNECTOR. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    OLYMPUS REVIEWED THE RECORD OF SERVICE FOR THE DEVICE PERFORMED PRIOR TO THE EVENT. ANNUAL INSPECTION BY OLYMPUS WAS CONDUCTED FOR THE SUBJECT DEVICE IN MAY 17TH, 2019. AS A RESULT OF THE ANNUAL INSPECTION, THERE WAS NO IRREGULARITY. A REPRESENTATIVE OF OLYMPUS VIETNAM CO., LTD.(OVN) HAD CONDUCTED THE REPROCESSING TRAINING FOR THE USER FACILITY TWO YEARS AGO. AFTER THE REPORTED EVENT OCCURRED, THE SUBJECT DEVICE WAS RETURNED TO OVN AND PASSED ALL FUNCTIONAL TESTS. AS OLYMPUS DIDN'T BECOME AWARE OF THE EVENT AT THAT MOMENT, THE SUBJECT DEVICE WAS LOANED TO ANOTHER HOSPITAL BETWEEN OCTOBER 16TH, 2019, AND OCTOBER 24TH, 2019. THERE WAS NO INCIDENT REPORT FROM THE HOSPITAL. THE SUBJECT DEVICE WAS RETURNED FROM THE HOSPITAL TO OVN ON OCTOBER 24TH, 2019. 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

    ON OCTOBER 22ND, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER FACILITY THAT THERE IS A POTENTIAL CROSS-INFECTION. ASIA-PACIFIC SOCIETY FOR DIGESTIVE ENDOSCOPY PROVIDED FIVE DAYS TRAINING COURSE FROM (B)(6) 2019, TO (B)(6) 2019, AT THE USER FACILITY. THIS TRAINING COURSE INCLUDED THREE LIVE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED BY LOCAL DOCTORS AND OLYMPUS DUODENOSCOPE TJF-Q180V WAS USED. THE PROCEDURE DATE OF THE THREE PATIENTS WERE AS FOLLOWS; FIRST PATIENT: (B)(6) 2019, SECOND PATIENT: (B)(6) 2019, THIRD PATIENT: (B)(6) 2019. THE THREE PATIENTS DEVELOPED A FEVER AFTER THE PROCEDURE. THE PATIENTS HAD ALREADY RECOVERED WHEN OLYMPUS BECAME AWARE OF THIS EVENT. IT WAS REPORTED THAT THE USER FACILITY CONDUCTED THE BLOOD TEST ON THREE PATIENTS, BUT THERE WAS NO RESULTS PROVIDED TO OLYMPUS. THE USER FACILITY DIDN'T CONDUCT MICROBIOLOGICAL TESTING FOR THE SUSPECTED DEVICE AND DIDN'T ALLEGE ANY FAILURE OF THE DEVICE. THE USER FACILITY HAD CLEANED THE ENDOSCOPES USING AN OLYMPUS CLEANING BRUSH (BW-20T, MH-507, AND MAJ-1888) AND UNSPECIFIED CLEANING BRUSH, AND MANUALLY REPROCESSED USING A NON-OLYMPUS DISINFECTANT. THE USER FACILITY REPORTEDLY WON'T DISCLOSE ANY FURTHER INFORMATION. OMSC IS SUBMITTING THREE MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE POTENTIALLY INFECTED PATIENTS. THIS IS ONE OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133911 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other