MalfunctionFGE
ZIMMON BILIARY STENT
Received Jul 29, 2026 · Event occurred Jun 25, 2026
Report 3001845648-2026-00301 · MDR key 50065166
Device
Generic name
Fge, Stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Cook Ireland LtdModel number
G22167Catalog number
ZSO-7-7
Lot number
C2374789
Product problems
- Dent in Material
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Description of EventWhen the nurse used the straightener, the stent was kinked.
Additional Manufacturer Narrative
D3, F14 and G1: County name is 'IE'Investigation is still pending, a follow up MDR will be submitted to include the investigation conclusions.