FDA Adverse Event
Malfunction
Summary report: N
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
MDR report key: 24554094
·
Received March 9, 2026
Report
- Report Number
- 9610595-2026-20028
- Event Type
- Malfunction
- Date Received
- March 9, 2026
- Report Date
- March 9, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED IT IS LIKELY DUE TO DUE TO DAMAGE ON CHARGED COUPLED DEVICE (CCD) UNIT, A NOISE IMAGE OCCURS (ELECTRICAL/ELECTRONIC COMPONENT PROBLEM). THE 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.
Description of Event or Problem · 0
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE FLEX DEFLECTABLE VIDEOSCOPE HAD ITS VISION GETTING FLUCTUATED, AND VERTICAL LINES COMING ON 3D VISION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615303 | ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE | FLEX DEFLECTABLE VIDEOSCOPE | GCJ | AIZU OLYMPUS CO., LTD. | LTF-S300-10-3D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |