ULTRASONIC GASTROVIDEOSCOPE
Report
- Report Number
- 3002808148-2024-05803
- Event Type
- Malfunction
- Date Received
- June 26, 2024
- Report Date
- July 16, 2024
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- ODG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION ADDED TO FIELD H3,H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE REPORTED MALFUNCTION (ACOUSTIC LENS CAME OFF) WAS CAUSED BY PHYSICAL STRESS; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED THE ACOUSTIC LENS COMING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577616 | ULTRASONIC GASTROVIDEOSCOPE | ULTRASONIC GASTROVIDEOSCOPE | ODG | SHIRAKAWA OLYMPUS CO., LTD. | GF-UE260-AL5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |