inforMED
InjuryMND

SINGLE USE LIGATING DEVICE

Received Nov 7, 2025 · Event occurred Oct 28, 2025

Report MW5178626 · MDR key 23497750

Device

Generic name

Ligator, Esophageal

Model number

HX-400U-30

Lot number

41V/V4102

Product problems

  • Mechanical Jam

Patient

46 YR · Female

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

Narrative

Description of Event or Problem

PATIENT SEEN FOR OUTPATIENT COLONOSCOPY. A LARGE POLYP WAS IDENTIFIED IN THE SIGMOID COLON. THE PHYSICIAN REQUESTED AN OLYMPUS LIGATING DEVICE FOR A POLYPECTOMY. THE DEVICE WAS OPENED AND SECURED AROUND THE POLYP WHEN IT WAS DISCOVERED THAT THE HANDLE OF THE DEVICE WOULD NOT RELEASE/DEPLOY. THE DEVICE WAS STUCK IN THE PATIENT SURROUNDING A LARGE POLYP WITH HIGH RISK OF HEMORRHAGE. THE DEVICE WAS ULTIMATELY CUT AND BURNED TO DETACH IT FROM THE COLONOSCOPE AND PATIENT. TOTAL TIME TO CORRECT - 70 MINUTES. PATIENT WILL BE GETTING A FOLLOW UP CT SCAN. PATIENT WILL NEED SURGERY. DEBATABLE ON IF THE PATIENT WOULD HAVE NEEDED SURGERY IF THE DEVICE DID NOT MALFUNCTION.