FDA Adverse Event
Malfunction
Summary report: N
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
MDR report key: 24929805
·
Received April 20, 2026
Report
- Report Number
- 9610595-2026-32288
- Event Type
- Malfunction
- Date Received
- April 20, 2026
- Report Date
- April 20, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE CHARGED COUPLED DEVICE COVER LENS GLUE PEELED OFF COULD NOT BE DETERMINED. 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 FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED THE CHARGED COUPLED DEVICE COVER LENS GLUE PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 990890 | 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 |