FDA Adverse Event
Malfunction
Summary report: N
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
MDR report key: 24989722
·
Received April 24, 2026
Report
- Report Number
- 3002808148-2026-13191
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Report Date
- April 24, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- PSV
- UDI-DI
- 04953170356353
- PMA / PMN Number
- K070983
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE OF THE REPORTED FAILURE 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.
Description of Event or Problem · 0
DURING THE DEVICE EVALUATION, CORROSION WAS FOUND ON THE ELECTRICAL CONNECTOR OF THE BRONCHO FIBER VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542773 | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | ULTRASONIC BRONCHOFIBERVIDEOSCOPE | PSV | SHIRAKAWA OLYMPUS CO., LTD. | BF-UC180F | 04953170356353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |