BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 17684868 · Received September 5, 2023

    Report

    Report Number
    2429304-2023-00281
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 5, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170434792
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TIP OF THE EVIS EXERA III BRONCHOVIDEOSCOPE BROKE INSIDE THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE PIECE WAS RETRIEVED WITH MINIMAL IMPACT TO THE PATIENT. THE COMPANY REPRESENTATIVE DID NOT KNOW EXACTLY WHAT CAUSED THE DAMAGE OR HOW BAD THE DAMAGE WAS AT THE TIME OF REPORT. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT. E1 - ESTABLISHMENT NAME: MEMORIAL SLOAN KETTERING CANCER CENTER FOR CANCER & ALLIED DISEASES (DOCUMENTED HERE IN ITS ENTIRETY DUE TO CHARACTER LIMITATIONS IN RESPECTIVE FIELD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378821 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-Q190 04953170434792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention