MalfunctionFCS
IRIS URETERAL KIT
Received Jun 29, 2026 · Event occurred Jun 4, 2026
Report 0002936485-2026-00416 · MDR key 25660277
Device
Generic name
Light, Catheter, Fiberoptic, Glass, Ureteral
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0220180518
Lot number
17380035
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 THE DEVICE FAILED DURING SURGERY. IT ONLY LIGHTS UP PART WAY.