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
Manufacturer
Stryker Endoscopy-san JoseCatalog 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