BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 20506281 · Received October 22, 2024

    Report

    Report Number
    3002808148-2024-10244
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    September 17, 2024
    Report Date
    February 6, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO PROVIDE AN UPDATE TO FIELD H4. 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 SUBJECT DEVICE WAS NOT RETURNED, AND AN SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED WITH THE INFORMATION RECEIVED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000447 THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT INJURY CAUSED WITH OLYMPUS DEVICES WHEN IN USE. THE CUSTOMER WAS USING A CAUTERY DEVICE FROM AN UNKNOWN MANUFACTURER ALONG WITH OLYMPUS SCOPE AND LIGHT SOURCE IN AN UNKNOWN PROCEDURE. THE IMAGE PRODUCED WAS DISTORTED AND THE PHYSICIAN COULD NOT SEE THE IMAGE PROPERLY. AS SUCH, THE PHYSICIAN ACCIDENTALLY PERFORATED THE PATIENT. THE PHYSICIAN WAS ABLE TO REPAIR THE DAMAGE AND FINISH THE PROCEDURE. THE CUSTOMER ADDITIONALLY NOTED THAT THE WIRING IN THAT ROOM WAS 20 YEARS OLD. REPORTEDLY, THE CAUTERY DEVICE WAS VERY CLOSE TO THE PATIENT TABLE AND UNLIKELY TO CAUSE DISTORTION. THE PATIENT ENDED UP IN THE INTENSIVE CARE UNIT AFTER THE PROCEDURE. FURTHER FOLLOW-UP WAS CONDUCTED, AND NO ADDITIONAL INFORMATION WAS RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005482 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CAUTERY DEVICE, UNKNOWN MANUFACTURER.| CLV-190, XENON LIGHT SOURCE, (B)(6).