MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-06 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
Report Number | 8010047-2019-02854 |
MDR Report Key | 8865874 |
Report Source | USER FACILITY |
Date Received | 2019-08-06 |
Date of Report | 2019-08-06 |
Date Mfgr Received | 2019-07-10 |
Date Added to Maude | 2019-08-06 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
Manufacturer Street | 2951 ISHIKAWA-CHO |
Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
Manufacturer Country | JA |
Manufacturer Postal | 192-8507 |
Manufacturer Phone | 426425177 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
Product Code | PSV |
Date Received | 2019-08-06 |
Model Number | BF-UC180F |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-08-06 |