FDA Adverse Event
Malfunction
Summary report: N
EVIS EXERA III COLONOVIDEOSCOPE
MDR report key: 23610669
·
Received November 20, 2025
Report
- Report Number
- 9610595-2025-33601
- Event Type
- Malfunction
- Date Received
- November 20, 2025
- Date of Event
- October 24, 2025
- Report Date
- November 20, 2025
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDF
- UDI-DI
- 04953170416118
- PMA / PMN Number
- K192793
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE COMPLAINT WAS REPORTED BECAUSE SCOPE NOT TAKING PICTURES. THE PRODUCT WAS RETURNED TO OLYMPUS SERVICE TEAM. THE COMPLAINT WAS CONFIRMED THE DEVICE HAS SCOPE NOT TAKING PICTURES. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS D02 - CAUSE TRACED TO COMPONENT FAILURE. 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 THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE WOULD NOT TAKE VIDEOS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292932 | EVIS EXERA III COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | AIZU OLYMPUS CO., LTD. | PCF-HQ190L | 04953170416118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |