SINGLE USE LOOP CUTTER FS-410
Received Mar 5, 2025 · Event occurred Feb 7, 2025
Report 9614641-2025-00257 · MDR key 21526993
Device
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATED FIELDS: A4, A5, B6, B7, D4 - EXPIRATION DATE NULL, D4UNIQUE DEVICE IDENTIFIER (UDI) #, D4-UNIQUE DEVICE IDENTIFIER (UDI) #1, D6A, D6B, D7A, D8, D9, D10, E1, G2, H2, H3, H4, H6, AND H11. CORRECTED FIELDS: E4. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHILE ATTEMPTING TO CUT THE SUTURE OF AN OLYMPUS SINGLE-USE LOOP CUTTER DURING A BRONCO PROCEDURE, THE DEVICE BIT THE THREAD AND COULD NOT COME OFF. ACCORDING TO THE INITIAL REPORTER, THE DEVICE CAME OFF IMMEDIATELY FOLLOWING THE COMPLETION OF THE PROCEDURE. REPORTEDLY, THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.