MalfunctionPLL
ORISE¿ GEL
Received Jun 17, 2022 · Event occurred Apr 29, 2022
Report 14731614 · MDR key 14731614
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationModel number
M00519221Lot number
28495035
Product problems
- Break
- Device Difficult to Setup or Prepare
Patient
13870 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ORISE LIFTING GEL SYRINGE TIP BROKE OFF PRIOR TO INJECTION. THIS HAPPENED ON TWO PRODUCTS BACK-TO-BACK. NO HARM TO PATIENT AS THIS THE MALFUNCTION HAPPENED PRIOR TO USE WITH THE PATIENT.