EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
Report
- Report Number
- 9610595-2025-11217
- Event Type
- Malfunction
- Date Received
- June 13, 2025
- Report Date
- July 30, 2025
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, G1, G2, H6 CORRECTED FIELDS: E2 - FROM N TO Y E3 - FROM N/A TO NURSE H6 (COMPONENT CODE) - FROM PROCESSOR TO IMAGER THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION HOWEVER, THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE EVENT IS DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED THE WATER FILTER HAD NOT BEEN REPLACED FOR ONE YEAR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344308 | EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE | FDS | AIZU OLYMPUS CO., LTD. | GIF-H290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |