FDA Adverse Event
Malfunction
Summary report: N
EVIS EXERA III COLONOVIDEOSCOPE
MDR report key: 24269344
·
Received February 5, 2026
Report
- Report Number
- 9610595-2026-12434
- Event Type
- Malfunction
- Date Received
- February 5, 2026
- Report Date
- February 5, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDF
- UDI-DI
- 04953170305177
- PMA / PMN Number
- K131780
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO OLYMPUS. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE REPORTED ISSUE OCCURRED DUE TO A BENT LIGHT SHEATH, A DAMAGED CONNECTOR, AND A DAMAGED CABLE. 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 · 0
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT WHEN THE COLONOVIDEOSCOPE WAS CONNECTED TO THE COLUMN, A 'CONNECTION ERROR' MESSAGE APPEARED AND NO IMAGE WAS DISPLAYED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329085 | EVIS EXERA III COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | AIZU OLYMPUS CO., LTD. | CF-H190I | 04953170305177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |