FDA Adverse Event
Malfunction
Summary report: N
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE
MDR report key: 25225600
·
Received May 19, 2026
Report
- Report Number
- 3002808148-2026-16930
- Event Type
- Malfunction
- Date Received
- May 19, 2026
- Date of Event
- May 12, 2026
- Report Date
- May 19, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- PSV
- UDI-DI
- 04953170399831
- PMA / PMN Number
- K183525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE ULTRASOUND BRONCHOFIBERVIDEOSCOPE HAD A GREENISH BLACK RESIDUE ON THE DISTAL END OF THE SCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102475 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE | PSV | SHIRAKAWA OLYMPUS CO., LTD. | BF-UC190F | 04953170399831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |