FDA Adverse Event
Malfunction
Summary report: N
VISERA PRO VIDEO SYSTEM CENTER
MDR report key: 18440496
·
Received January 3, 2024
Report
- Report Number
- 3002808148-2024-30016
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- December 7, 2023
- Report Date
- January 3, 2024
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- UDI-DI
- 04953170228896
- PMA / PMN Number
- K062049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
E1 : (B)(6). G1: MANUFACTURING CONTACT FACILITY NAME: SHIRAKAWA OLYMPUS CO., LTD. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. 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.
Description of Event or Problem · 0
THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA PRO VIDEO SYSTEM CENTER HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587042 | VISERA PRO VIDEO SYSTEM CENTER | VIDEO SYSTEM CENTER | FET | SHIRAKAWA OLYMPUS CO., LTD. | OTV-S7PRO | 04953170228896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |