MalfunctionFGO
ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
Received Jul 7, 2026 · Event occurred Jun 1, 2026
Report 3011050570-2026-00705 · MDR key 25733310
Device
Generic name
Ultra-catch Nt (1.8 Fr X 115 Cm) Stone Retrieval Device
Manufacturer
Gyrus Acmi, Inc.Model number
NT4W18115Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED GRASPER OF DEVICE BROKE OFF DURING A THERAPEUTIC URETEROSCOPY PROCEDURE INVOLVING AN OLYMPUS STONE RETRIEVAL DEVICE. THERE WAS NO PATIENT INJURY REPORTED.