MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[116739811]
The referenced uhi-4 was not returned to olympus medical systems corp. (omsc) for evaluation at this time, therefore omsc could not evaluate the uhi-4. The uhi-4 was returned to olympus (b)(4). (b)(4) evaluated the uhi-4 and found that the user? S report could not be duplicated. Also there was not any abnormal exterior on the uhi-4, however there was damage on the parts of the pc board inside of the uhi-4. (b)(4) exchanged the parts to new one. The referenced uhi-4 is planned to return to omsc. There were no further details provided. The exact cause of the reported event could not be conclusively determined at this time. If additional information, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[116739812]
Olympus was informed that during the adrenal surgery, the pressure of the uhi-4 became abnormally and the patient? S abdominal cavity got gradually small. The facility changed the uhi-4 to the other similar device and the procedure was completed. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01556 |
| MDR Report Key | 7755628 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-07-24 |
| Date Added to Maude | 2018-08-07 |
| 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 | HIGH FLOW INSUFFLATION UNIT |
| Generic Name | HIGH FLOW INSUFFLATION UNIT |
| Product Code | FCX |
| Date Received | 2018-08-07 |
| Returned To Mfg | 2018-07-30 |
| Model Number | UHI-4 |
| Device Availability | R |
| 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 | 2018-08-07 |