MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-01 for EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC260FW manufactured by Olympus Medical Systems Corp..
[115778387]
The subject device had not been returned to olympus medical systems corp. But was returned to olympus (b)(4). In the evaluation, there was the following abnormality. The fixing of the up-angle wire was uncoupled. As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at present. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[115778388]
Olympus was informed that the bending section of the subject device stopped working during a bronchoscopy after passing of an unspecified needle into the channel. The facility replaced the subject device with a similar but different bronchoscopic and completed the procedure. There was no patient injury report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01498 |
| MDR Report Key | 7738212 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-01 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2015-11-04 |
| Date Added to Maude | 2018-08-01 |
| 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 LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2018-08-01 |
| Model Number | BF-UC260FW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-08-01 |