MalfunctionFGX
EXACTO
Received Jul 16, 2026 · Event occurred Jun 19, 2026
Report 1528319-2026-00082 · MDR key 25840333
Device
Generic name
Snare
Manufacturer
Us EndoscopyModel number
00711115Catalog number
00711115
Lot number
(10)13764210
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE SNARE TO THEIR EXACTO COLD SNARE WAS STUCK ON THE PATIENT'S TISSUE. THE USER FACILITY DID NOT DISCLOSE WHETHER ADDITIONAL MEDICAL TREATMENT WAS REQUIRED. NO REPORT OF INJURY.
Additional Manufacturer Narrative
THE INVESTIGATION OF THE REPORTED EVENT IS IN PROCESS. THE DEVICE IS BEING RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.