UNIVERSA SOFT URETERAL STENT SET
Received Apr 22, 2026 · Event occurred Apr 15, 2026
Report 1820334-2026-00436 · MDR key 24952985
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ONE SIDE OF THE UNIVERSA SOFT URETERAL STENT TIP WAS FOUND TO BE BROKEN WHEN THE PACKAGE WAS OPENED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. A NEW SAME DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Additional Manufacturer Narrative
H3 - DEVICE EVALUATED BY MFG?: DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.