EVIS EXERA II BRONCHOVIDEOSCOPE
Report
- Report Number
- 9610595-2025-40010
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Report Date
- May 29, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- EOQ
- PMA / PMN Number
- K061313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 501
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT IS RELATED TO MFR REPORT # 9610595-2025-39843 (10/10).
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATES FIELDS: G3, H2, H3, H6 AND H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION THE CUSTOMER ALLEGATION WAS NOT CONFIRMED. ADDITIONALLY, THE INVESTIGATION OBSERVED DAMAGE TO THE CHANNEL MOUNT AND DAMAGE TO THE MOUTH GUARD PIECE FOR ENDOSCOPY. THE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE CUSTOMER REPORTED HAVING USED THE BRONCHOVIDEOSCOPE ON 10 PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18463 | EVIS EXERA II BRONCHOVIDEOSCOPE | BRONCHOVIDEOSCOPE | EOQ | AIZU OLYMPUS CO., LTD. | BF-1T180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |