MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[118546464]
The device has not been returned to omsc for evaluation. Omsc reviewed the manufacturing history of this device and confirmed no irregularity. 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
[118546465]
Olympus medical systems corp. (omsc) was informed that as a result of microbiological testing by the user facility, mycobacterium lentiflavum were detected from the sample collected from the subject device. The number of microbes is unknown. The device had been reprocessed using an olympus automated endoscope reprocessor model mini etd2 (not available in the usa) with peracetic acid. The user facility reported that microbes were detected from three different devices including the subject device and there was a possibility that patients (up to 20 patients) who used these devices were infected. However, at this time there is no report of patient infection associated with this report. This is 2nd of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01657 |
| MDR Report Key | 7821678 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-08-28 |
| Device Manufacturer Date | 2008-07-17 |
| Date Added to Maude | 2018-08-28 |
| 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 | 2018-08-28 |
| 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 | 2018-08-28 |