ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
Received Feb 5, 2026 · Event occurred Jan 20, 2026
Report 3011050570-2026-00138 · MDR key 24269351
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 MDR SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATED FIELDS AND FINAL INVESTIGATION RESULTS. THE DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE TRACED TO COMPONENT FAILURE. OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
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
IT WAS REPORTED THE ULTRA-CATCH NT STONE RETRIEVAL DEVICE WAS BROKEN WHEN DEPLOYED. THE ISSUE OCCURRED DURING A THERAPEUTIC URETHROSCOPY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.