UNIVERSA SOFT URETERAL STENT SET
Received Jun 4, 2026 · Event occurred May 19, 2026
Report 1820334-2026-00592 · MDR key 25392135
Device
Product problems
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, ADHESIVE RESIDUE WAS FOUND ON THE UNIVERSA SOFT URETERAL STENT SET UPON REMOVAL FROM ITS PACKAGING, RENDERING THE DEVICE UNUSABLE. AS SUCH, THE PHYSICIAN REPLACED IT WITH A NEW SAME-LIKE DEVICE TO SUCCESSFULLY COMPLETE THE SURGERY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Additional Manufacturer Narrative
H3 ¿ THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. 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 COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.