EVIS LUCERA COLONOVIDEOSCOPE
Report
- Report Number
- 9610595-2026-12306
- Event Type
- Malfunction
- Date Received
- February 5, 2026
- Date of Event
- January 24, 2026
- Report Date
- March 10, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. UPDATED FIELDS: H2, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION OF THE COLONOVIDEOSCOPE DID NOT COMPLETE A FULL CYCLE IN THE ENDOSCOPE WASHER DISINFECTORS (EWD) DURING REPROCESSING WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE ROOT CAUSE WAS A CLOGGED NOZZLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DID NOT COMPLETE A FULL CYCLE IN THE ENDOSCOPE WASHER DISINFECTORS (EWD) DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330693 | EVIS LUCERA COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | AIZU OLYMPUS CO., LTD. | CF-Q260DL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |