BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX ENDOSCOPE EG 2990I

    MDR report key: 19994264 · Received August 14, 2024

    Report

    Report Number
    MW5158441
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 9, 2024
    Manufacturer
    HOYA CORPORATION PENTAX LIFECARE DIVISION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON REMOVAL OF ENDOSCOPE AND POST FLUSHING WITH A CLEAR FLUID, PARTICLES RESEMBLING BLACK PLASTIC WAS OBSERVED IN THE CONTAINER HOLDING THE FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176942 PENTAX ENDOSCOPE EG 2990I GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS HOYA CORPORATION PENTAX LIFECARE DIVISION EG 2990I

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female