VISERA ELITE II VIDEO SYSTEM CENTER
Report
- Report Number
- 3002808148-2024-00076
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- December 11, 2023
- Report Date
- February 5, 2024
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- UDI-DI
- 04953170386022
- PMA / PMN Number
- K200542
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKE THAT THE EVENT REPORTED AS "ERROR E226" WAS CAUSED BY THE BENT PINS IN THE VIDEO SOCKET. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEO PROCESSOR HAS SCOPE COMMUNICATION ERROR E226 . THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC CYSTOSCOPY PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM.
THE CUSTOMER REPORTED THAT THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1550598 | VISERA ELITE II VIDEO SYSTEM CENTER | VIDEO SYSTEM CENTER | FET | SHIRAKAWA OLYMPUS CO., LTD. | OTV-S200 | 04953170386022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |