DISPOSABLE BENDING CANNULA
Received Dec 4, 2025 · Event occurred Nov 6, 2025
Report 9614641-2025-02005 · MDR key 23718808
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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. UPDATED FIELDS: D4, D9, H2, H3, H4, H6, H11 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: THE SLIDER WAS PULLED TOO HARD WHEN THE TIP WAS DIFFICULT TO BEND, CAUSING A LOAD GREATER THAN THE WIRE'S TOLERANCE TO BE APPLIED. 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
E1: (B)(6). THE EVALUATION OF THE EVENT 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 THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE BENDING CANNULA WIRE BROKE. IT WAS REPORTED THAT IT DID NOT FALL OFF INSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.