EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Report
- Report Number
- 9610595-2026-29548
- Event Type
- Malfunction
- Date Received
- April 11, 2026
- Date of Event
- March 12, 2026
- Report Date
- April 10, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDS
- UDI-DI
- 04953170305276
- PMA / PMN Number
- K131780
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- 501
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS INCLUDE D9, H2, H3, H6, AND H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE DISPLAYED A DUAL FOCUS SCOPE COMMUNICATION ERROR (E402), O/DF WAS NOT CONNECTED, AND WOULD NOT TAKE PICTURES. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 912098 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE | FDS | AIZU OLYMPUS CO., LTD. | GIF-HQ190 | 04953170305276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |