FDA Adverse Event
Malfunction
Summary report: N
VISERA ELITE III VIDEO SYSTEM CENTER
MDR report key: 24166680
·
Received January 23, 2026
Report
- Report Number
- 3002808148-2026-02297
- Event Type
- Malfunction
- Date Received
- January 23, 2026
- Report Date
- May 19, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- PMA / PMN Number
- K251336
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO A PREVIOUSLY SUBMITTED REPORT. THIS EVENT WAS REPORTED AS A DUPLICATE REPORT. PLEASE REFER TO MFG REPORT # 3002808148-2026-01129-00.
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
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Description of Event or Problem · 0
IT WAS REPORTED THE VIDEO SYSTEM CENTER PRESENTED AN E226 SCOPE COMMUNICATION ERROR DUE TO THE FAULTY CAMERA CABLE AND CCD ISSUE. THE ISSUE OCCURRED DURING INSPECTION FOR USE, BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440025 | VISERA ELITE III VIDEO SYSTEM CENTER | VIDEO SYSTEM CENTER | FET | SHIRAKAWA OLYMPUS CO., LTD. | OTV-S700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |