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MalfunctionOWN

FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM

Received Jul 15, 2026 · Event occurred Mar 9, 2026

Report 0002936485-2026-00482 · MDR key 25834064

Device

Generic name

Confocal Optical Imaging

Catalog number

0233050400

Lot number

19008

Product problems

  • Overheating of Device

Patient

Unknown

  • Burn(s)

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE SCOPE ACCIDENTALLY CAME OFF THE LIGHT CORD, THE SAFETY FEATURE OF THE LIGHT CORD TURNING OFF FAILED AND THIS RELATED IN THE POTENTIAL BURN INJURY OF A PATIENT