MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for UNKNOWN manufactured by Olympus Medical Systems Corp..
[72663932]
The subject device is not returned to olympus for evaluation, therefore olympus cannot evaluate the subject device. The exact cause of the reported event could not be conclusively determined at this time. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[72663933]
After an unspecified endoscopy treatment with an unspecified device, the user facility found emboli in a patient's brain. The user facility dose not remember whether they used air or co2. There was no report of the patient injury other than above.
Patient Sequence No: 1, Text Type: D, B5
[73283325]
This is a supplemental report for mfr report #8010047-2017-00369 to provide additional information. Although the device used for the procedure is not clear, we added information about possible device related to the patient injury.
Patient Sequence No: 1, Text Type: N, H10
[74291265]
This is a supplemental report for mfr report #8010047-2017-00369. Olympus obtained the following information. The user facility reported that the incident was not related to the device of olympus. Olympus concluded that this phenomenon did not cause by the device of olympus.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2017-00369 |
| MDR Report Key | 6445021 |
| Date Received | 2017-03-29 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-03-29 |
| 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 HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | CO2 REGULATION UNIT |
| Product Code | FCX |
| Date Received | 2017-03-29 |
| Model Number | UNKNOWN |
| 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 | 1. Other | 2017-03-29 |