BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH INTENSITY XENON LIGHT SOURCE

    MDR report key: 24477478 · Received February 27, 2026

    Report

    Report Number
    9610617-2026-00398
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 1, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE MATERIAL NUMBER WAS DIFFERENT THAN ORIGINALLY REPORTED. THE AFFECTED MATERIAL NUMBER IS FROM FDA PRODUCT CODE FCW. A REVIEW OF PREVIOUS COMPLAINTS REVEALED THERE HAS NEVER BEEN A DEATH OR SERIOUS INJURY RELATED TO THE REPORTED MALFUNCTION; THEREFORE, WE HAVE DETERMINED THAT THIS EVENT IS NOT REPORTABLE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, WE WILL REASSESS THE REPORTABILITY OF THIS EVENT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION IN SECTION D LEADING DEVICE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    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

    IT WAS REPORTED THAT "DURING A LAPAROSCOPIC HERNIA REPAIR SURGERY, THE OPTICAL FIBER SUDDENLY FAILED TO LIGHT UP. UNABLE TO PERFORM SURGERY NORMALLY. ON-SITE ENGINEER INSPECTION CONFIRMED FAILURE OF THE ENDOSCOPE'S INTERNAL LAMP BULB, CAUSING FIBER OPTIC LIGHT FAILURE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571410 HIGH INTENSITY XENON LIGHT SOURCE HIGH INTENSITY XENON LIGHT SOURCE FCW KARL STORZ SE & CO. KG 20134001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown