MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[125117130]
The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to olympus (b)(4) for evaluation. (b)(4) confirmed the followings in the evaluation. Wear and tear on the bending rubber. Scratches and dents on the distal end. Incise on the ultrasonic transducer. 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 is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[125117131]
Olympus medical systems corp. (omsc) was informed that as a result of microbiological testing by the user facility, the sample collected from the subject device tested positive for unspecified microbes (>100cfu). Other detailed information such as the reprocessing method was not provided. There was no report of infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01901 |
| MDR Report Key | 7921690 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-10-01 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2016-09-16 |
| Date Added to Maude | 2018-10-01 |
| 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 | 0 |
| Brand Name | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2018-10-01 |
| Model Number | BF-UC180F |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-10-01 |