MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[90628999]
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 beijing (osh). Osh evaluated the uhi-4 and found that there was no damage on the exterior appearance of the uhi-4, however the uhi-4 did not start up when the uhi-4 was turned power on. Osh exchanged the main circuit board of the uhi-4 to another main circuit board, the uhi-4 started up without any problem. 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
[90629000]
Olympus was informed that during the preparation of the laparoscopic cholecystectomy, the uhi-4 could not operate. The patient was already under anesthesia. 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 | 8010047-2017-01490 |
| MDR Report Key | 6957320 |
| Date Received | 2017-10-18 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-09-19 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-10-18 |
| 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 KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| 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 | 2017-10-18 |
| Model Number | UHI-4 |
| 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 | 2017-10-18 |