MalfunctionFCS
IRIS URETERAL KIT
Received May 6, 2026 · Event occurred Apr 8, 2026
Report 0002936485-2026-00286 · MDR key 25105810
Device
Generic name
Light, Catheter, Fiberoptic, Glass, Ureteral
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0220180518
Lot number
17321019
Product problems
- Optical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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 DURING A PROCEDURE ONLY ONE OF TWO STENTS WERE LIGHTING UP WHEN USED WITH MULTIPLE LIGHT SOURCES.