inforMED
MalfunctionPTS

SINGLE USE ROTATABLE GRASPING FORCEPS FG-244NR

Received Nov 6, 2024 · Event occurred Sep 9, 2024

Report 20619695 · MDR key 20619695

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered, Exempt

Model number

FG-244NR

Lot number

4K6131

Patient

81 YR · Male

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

Narrative

Description of Event or Problem

WHILE USING GRASPING FORCEPS TO REMOVE BILIARY STENT, A PIECE OF PLASTIC BROKE OFF HANDLE OF THE FORCEPS CAUSING FORCEPS TO MALFUNCTION. THE STENT WAS STUCK IN THE WORKING CHANNEL OF THE SCOPE AND WAS ABLE TO BE REMOVED. NO HARM TO THE PATIENT.