MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[134982076]
The subject device has not been returned to omsc but was returned to olympus (b)(4). (b)(4) sent the device to a third party laboratory for microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the instrument channel, the air/water channel and the distal end of the device. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[134982077]
Olympus medical systems corp. (omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from instrument channel of the subject device tested positive for staphylococcus sp. The user facility did not provide other detailed information such as the number of microbes. The device had been reprocessed with a non-olympus automated endoscope reprocessor, belimed. There was no report of infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-00957 |
| MDR Report Key | 8276719 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-25 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2016-04-07 |
| Date Added to Maude | 2019-01-24 |
| 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 | 0 |
| Brand Name | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2019-01-24 |
| Model Number | BF-UC180F |
| 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 | 2019-01-24 |