MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-07 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[128254825]
The subject device has not been returned to omsc. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[128254826]
Olympus medical systems corp. (omsc) was informed that a wire sticking out from the insertion tube of the subject device was found during incoming inspection at olympus repair service center. Other detailed information such as when the event occurred was not provided from the user facility. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02138 |
| MDR Report Key | 8045395 |
| Report Source | FOREIGN |
| Date Received | 2018-11-07 |
| Date of Report | 2018-12-13 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-11-07 |
| 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 | 2018-11-07 |
| Model Number | BF-UC180F |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-07 |