FDA Adverse Event
Malfunction
Summary report: N
HIGH DEFINITION LCD MONITOR
MDR report key: 24400607
·
Received February 20, 2026
Report
- Report Number
- 3002808148-2026-04791
- Event Type
- Malfunction
- Date Received
- February 20, 2026
- Date of Event
- January 23, 2026
- Report Date
- May 26, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- PMA / PMN Number
- K102379
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THE HIGH-DEFINITION LCD MONITOR STOPPED DISPLAYING A SCOPE IMAGE DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537256 | HIGH DEFINITION LCD MONITOR | HIGH DEFINITION LCD MONITOR | FET | SHIRAKAWA OLYMPUS CO., LTD. | OEV262H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |