MalfunctionPLL
ORISE¿ GEL
Received Aug 15, 2022 · Event occurred Jul 28, 2022
Report 15224473 · MDR key 15224473
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationModel number
M00519220Catalog number
M00519220
Lot number
28984525
Product problems
- Break
- Insufficient Flow or Under Infusion
Patient
23360 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE USING THE ORISE GEL DURING THE ENDOSCOPY, THE GLASS SYRINGE BROKE IN MY HAND. IT HAD ABOUT 3 CC LEFT TO USE WHICH WE WOULD HAVE USED HAD THE SYRINGE NOT BROKEN.