BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 20212176 · Received September 13, 2024

    Report

    Report Number
    9610595-2024-18290
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 7, 2024
    Report Date
    January 2, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE DEVICE IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000409.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S (LM) REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES, THE DEVICE EVALUATION, RESULTS OF THIRD-PARTY TESTING, AND LMS FINAL INVESTIGATION. ADDITIONALLY, TO PROVIDE AN UPDATES TO FIELDS (D8, H3, AND H4). THE LM REVIEWED THE CUSTOMERS PROVIDED THE CDS PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM THE INSTRUCTION FOR USE (IFU) WERE IDENTIFIED. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE THIRD PARTY CULTURE RESULTS WERE POSITIVE. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: BIOPSY CHANNEL, SUCTION CHANNEL. CFU: UNKNOWN (BLOOD AGAR). BACTERIAL IDENTIFICATION: BACILLUS LICHENIFORMIS. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: BIOPSY CHANNEL, SUCTION CHANNEL. CFU: UNKNOWN (SABOURAUD DEXTROSE AGAR). BACTERIAL IDENTIFICATION: BACILLUS LICHENIFORMIS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE SUBJECT EVENTS WERE UNABLE TO BE DETERMINED. THE SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO A2, A3, A4, A6, B2, B5, B7, E2, E3, G2, AND H6 FOR INFORMATION INADVERTENTLY LEFT OUT FROM THE INITIAL MDR. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN UNSPECIFIED INFECTION AFTER THE DUODENO VIDEOSCOPE WAS USED ON THEM. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS READMITTED WITH INFECTION AND EXHIBITED TACHYCARDIA, HYPOTHERMIA, AND A RIGID/SWOLLEN ABDOMEN. BLOOD CULTURE WAS POSITIVE FOR S. MARCESCENS AND E. FAECALIS. THE PATIENT WAS TREATED WITH ZOSYN. THE PATIENT IS STABLE AND HAS BEEN DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208925 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention| O| H