MalfunctionPLL
ORISE GEL
Received Feb 7, 2020 · Event occurred Jan 7, 2020
Report 9681247 · MDR key 9681247
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationCatalog number
M06519221
Product problems
- Detachment of Device or Device Component
Patient
19710 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
GEL TUBE SYRINGE TIP BROKE OFF DURING COLONOSCOPY PROCEDURE.