MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[106976352]
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 samples taken from the distal end, the instrument and the balloon channels of the device. As the result of this device confirmation by (b)(4), although the following irregularity was confirmed for this device, the causal relation with this case is unknown. Two broken image guide fibers are visible in the endoscopic image. The endoscopic image is slightly unsharp. Four ultrasound wires are broken of the probe unit. Distal end is heavily scratched with a sharp edge. Omsc reviewed the manufacture history of the 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
[106976353]
Olympus medical systems corp. (omsc) was informed that during three times microbiological testing by the user facility, following microbes were detected three times from the subject device. The facility did not provide other detailed information such as the number and the type of microbes. The device had been reprocessed with an olympus automated endoscope reprocessor model etd-3 (not available in the usa). There was no report of infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00702 |
| MDR Report Key | 7450022 |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-23 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2016-06-29 |
| Date Added to Maude | 2018-04-23 |
| 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 | 2018-04-23 |
| Model Number | BF-UC180F |
| ID Number | 04953170356360 |
| 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 | 2018-04-23 |