MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[111020400]
The subject device has not been returned to omsc for evaluation. The exact cause could not be determined at present. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[111020401]
Olympus medical systems corp. (omsc) was informed that during a unspecified bronchoscope procedure, the user facility noticed that a unspecified tube stuck within the instrument channel of the subject device when inserting a non-olympus biopsy needle (endo flex nebs41 221-c) into the channel. The facility reported that no obstruction was observed in the channel during the cleaning right before the procedure. Other detailed information was not provided from the user facility but there was no report of patient injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01117 |
| MDR Report Key | 7590023 |
| Date Received | 2018-06-11 |
| Date of Report | 2018-07-26 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-06-11 |
| 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 | 2018-06-11 |
| Returned To Mfg | 2018-05-30 |
| Model Number | BF-UC180F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-06-11 |