MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[128613318]
The device has not been returned to olympus medical systems corp. (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
[128613319]
Olympus was informed that the subject device tested positive for unspecified bacteria(6cfu/endoscope) during routine surveillance culturing test by the facility. The portion of the subject device, where the microbes were detected, were not reported. The subject device had been disinfected using olympus automated endoscope reprocessor model etd (not available in the u. S. A) with peracetic acid(olympus endodis). There was no report of patient infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02292 |
| MDR Report Key | 8105280 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2018-08-06 |
| Date Added to Maude | 2018-11-27 |
| 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 | 2018-11-27 |
| Model Number | BF-UC180F |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-27 |