IRIS URETERAL KIT
Received Jul 9, 2026 · Event occurred Jun 11, 2026
Report 0002936485-2026-00455 · MDR key 25770920
Device
Generic name
Light, Catheter, Fiberoptic, Glass, Ureteral
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0220180518
Lot number
UNKNOWN
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 THE DURING PROCEDURE, THE STENT LOOKED TO BE MORE OF A 'BALL' VS THE NORMAL WAY THAT IT LOOKED. THE SURGEON AND NURSES DEEMED THAT THE FIBER OPTIC CABLE COILED IN SOME WAY. THE UROLOGIST ITSELF SEEMED HAPPY WITH THE INITIAL PLACEMENT OF EVERYTHING.