inforMED
MalfunctionPLL

ENDOCLOT

Received Apr 24, 2023

Report 3013155768-2023-00005 · MDR key 16803061

Device

Generic name

Submucosal Injection System

Model number

SIS-15-01

Catalog number

SIS-15-01

Product problems

  • Break
  • Break

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE USER REPORTED THAT THE SYRINGE OF SIS-15-01 DISTAL PORTION BROKE OFF AND THE TECHNICIAN WAS SPRAYED WITH THE FLUID. INJURY WAS NOT REPORTED.