BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GU CAMERA

    MDR report key: 15470502 · Received September 22, 2022

    Report

    Report Number
    MW5112225
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 20, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OLYMPUS CAMERA MODEL NUMBER CH-S190-08-LB, THERE WAS CRACKS AND BROKEN PIECES ON THE PADDLE OF THIS CAMERA WHICH HOUSED WATER AND COULD SHORT CIRCUIT THE TOWERS. MULTIPLE NEW CAMERAS EXPERIENCED THE SAME PROBLEM. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419331 GU CAMERA ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-08-LB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown