VORTEK DOUBLE LOOP URETERAL STENT KIT
Received May 26, 2026 · Event occurred Apr 27, 2026
Report 9610711-2026-00161 · MDR key 25281044
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
ACB163
Lot number
10819677_ACB1634002
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING THE PROCEDURE FOR PLACING THE DOUBLE J URETERAL STENT, WHICH OCCURRED WITHOUT ANY RESISTANCE OR FORCE. AT THE MOMENT OF EXTRACTING THE PUSHER USED WITH THE APPROPRIATE STYLET, WE FOUND A COMPLETE BREAK AT ABOUT ONE-THIRD OF THE PUSHER. THE REMAINING PART WAS RECOVERED FROM INSIDE THE INSTRUMENT BY PUSHING IT OUT OF THE OPERATING CHANNEL WITH A 6 CH STENT WITHOUT ANY DIFFICULTY, VERIFYING ITS CORRECT LENGTH.