SINGLE USE LIGATING DEVICE
Received Nov 7, 2025 · Event occurred Oct 28, 2025
Report MW5178626 · MDR key 23497750
Device
Generic name
Ligator, Esophageal
Manufacturer
Olympus Medical Systems CorpModel number
HX-400U-30Lot 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.