MalfunctionFGE
ZIMMON BILIARY STENT
Received Jul 3, 2026 · Event occurred Jun 5, 2026
Report 3001845648-2026-00263 · MDR key 25703376
Device
Generic name
Fge Stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Cook Ireland LtdModel number
G21982Catalog number
ZSO-10-9
Lot number
C2049580
Product problems
- Dent in Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Description of Event or Problem
DESCRIPTION OF EVENT WHEN THE NURSE USED THE STRAIGHTNER, THE STENT WAS KINK