MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[146662812]
The subject device has not been returned to omsc, but was returned to ode. The evaluation confirmed that the distal end of the subject device detached from the insertion tube. 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
[146662813]
Olympus medical systems corp. (omsc) was informed that there was a protruding metal material from the bending rubber during the receipt inspection of the subject device returned from the user facility at the olympus (b)(4). There was no information when the protrusion occurred. There was no report of patient injury associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-02042 |
| MDR Report Key | 8648834 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-06-06 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2013-05-09 |
| Date Added to Maude | 2019-05-29 |
| 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 | 2019-05-29 |
| 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 | 2019-05-29 |