LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
Received Feb 20, 2026 · Event occurred Jan 21, 2026
Report 9610773-2026-01267 · MDR key 24402375
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AT THE END OF A THERAPEUTIC TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE LASTING APPROXIMATELY 40 MINUTES, THE OPTICAL TUBE WAS REMOVED FROM THE LIGHT GUIDE AND THE LIGHT GUIDE CABLE WAS LEFT ON THE PATIENT¿S LOWER ABDOMEN. THIS RESULTED IN A FULL-THICKNESS (THIRD-DEGREE) BURN MEASURING APPROXIMATELY 1.0¿1.5 CM, WHICH WAS TREATED WITH TOPICAL MEDICATION. THE PATIENT WAS PLACED UNDER OBSERVATION BY THE PLASTIC SURGERY DEPARTMENT. THE PATIENT¿S CURRENT CONDITION IS REPORTED AS GOOD.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.