NITI-S EUS-BD SYSTEM
Received Jun 10, 2026 · Event occurred May 15, 2026
Report 3003902943-2026-00014 · MDR key 25465624
Device
Product problems
- Difficult to Insert
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED VERY STRONG RESISTANCE DURING INSERTION OF THE DELIVERY SYSTEM. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. FROM THE ATTACHED PHOTO, IT WAS OBSERVED THAT THE TIP WAS DETACHED. HOWEVER, IT IS HARD TO EXACTLY ANALYZE BECAUSE THE DEVICE WAS NOT RETURNED YET. INVESTIGATION WILL BE CONDUCTED ONCE DEVICE IS RETURNED AND WE WILL SEND FOLLOW-UP REPORT ACCORDINGLY.
Description of Event or Problem
THE PHYSICIAN ENCOUNTERED VERY STRONG RESISTANCE DURING INSERTION OF THE DELIVERY SYSTEM. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM FROM THE ENDOSCOPE AND FOUND THAT THE APPEARANCE OF THE TIP OF THE DELIVERY SYSTEM WAS DIFFERENT FROM THE USUAL. OUR SALES REPRESENTATIVE FOUND THAT THE DISTAL SIDE OF THE STENT WAS POSITIONED BEYOND THE EDGE OF THE TIP. THE APPEARANCE OF THE TIP OF THE DELIVERY SYSTEM BEFORE USE IS UNKNOWN. ANOTHER STENT (B)(6) WAS USED TO FINISH THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.