VISERA ELITE VIDEO SYSTEM CENTER
Report
- Report Number
- 3002808148-2025-01475
- Event Type
- Malfunction
- Date Received
- January 28, 2025
- Date of Event
- January 9, 2025
- Report Date
- April 23, 2025
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- PMA / PMN Number
- K111425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6 AND H11. THE DEVICE WAS NOT RETURNED TO THE REGIONAL SERVICE CENTER FOR INSPECTION AND THE REPORTED FAILURES WERE NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: REGARDING THE CUSTOMER¿S ALLEGATION, SINCE THE HAS SCOPE CONNECTOR SOCKET WAS LOOSE IMAGE HAS NOISE IS CAUSE NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
IT WAS REPORTED THE VISERA ELITE VIDEO SYSTEM CENTER EXPERIENCED SCOPE CONNECTOR SOCKET ISSUE DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2397414 | VISERA ELITE VIDEO SYSTEM CENTER | VIDEO SYSTEM CENTER | FET | SHIRAKAWA OLYMPUS CO., LTD. | OTV-S190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |