IRIS URETERAL KIT
Received Feb 15, 2024 · Event occurred Jan 19, 2024
Report 0002936485-2024-00133 · MDR key 18717280
Device
Generic name
Light, Catheter, Fiberoptic, Glass, Ureteral
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0220180518
Lot number
10286708
Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 BROKE DURING THE PROCEDURE.
Additional Manufacturer Narrative
ALLEGED FAILURE: FIBER BROKE WHEN UROLOGIST WAS TRYING TO PUSH INTO CATHETER. THEY OPENED A NEW KIT AND THEN IT WORKED FINE. SALESFORCE CASE NUMBER (B)(4) THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE EXCESSIVE BENDING DURING SET UP OR EXTREME SHIPPING OR STORAGE CONDITIONS. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE.