EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE
Report
- Report Number
- 3002808148-2026-05925
- Event Type
- Malfunction
- Date Received
- March 4, 2026
- Report Date
- March 11, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- PSV
- PMA / PMN Number
- K183525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS SUBMITTED TO DOCUMENT THE FINDINGS AND CONCLUSIONS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE AFFECTED DEVICE WAS RETURNED TO OLYMPUS AMERICA INC. AND UNDERWENT PHYSICAL INSPECTION. FOLLOWING A THOROUGH EVALUATION OF THE RETURNED DEVICE, THE REPORTED MALFUNCTION ¿ SPECIFICALLY, A MISSING FRONT-END PIN ¿ COULD NOT BE CONFIRMED. BASED ON THE FINDINGS OF THE COMPLETED INVESTIGATION, AND GIVEN THAT THE REPORTED DEVICE MALFUNCTION WAS NOT CONFIRMED DURING PHYSICAL EVALUATION OF THE RETURNED DEVICE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THAT DURING INSPECTION FOR USE, THE FRONT END PIN ON THE BRONCHOVIDEOSCOPE WAS FOUND TO BE MISSING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 477480 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE | PSV | SHIRAKAWA OLYMPUS CO., LTD. | BF-UC190F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |