BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-MAC MONITOR FOR CMOS ENDOSCOPES

    MDR report key: 22238214 · Received June 17, 2025

    Report

    Report Number
    2020550-2025-01046
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 17, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    "THE VIDEOLARYNGOSCOPE HAS A LOOSE CONNECTION. SUDDEN LOSS OF IMAGE DURING INTUBATION. THIS POSES A LIFE-THREATENING SITUATION FOR THE PATIENT AND HER UNBORN CHILD." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, FURTHER INFORMATION ABOUT THE PATIENT OUTCOME PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628845 C-MAC MONITOR FOR CMOS ENDOSCOPES C-MAC MONITOR FOR CMOS ENDOSCOPES CCW KARL STORZ SE & CO. KG 8403ZX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening