MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-12 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[102447167]
The referenced uhi-4 is planned to return to olympus medical systems corp. (omsc) for evaluation, however the uhi-4 is not returned to omsc yet, therefore omsc cannot evaluate the uhi-4. 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
[102447168]
Olympus was informed that during the unspecified surgery, the uhi-4 could not insufflate the patient? S abdominal cavity. The facility changed the uhi-4 to the other unspecified 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 | 8010047-2018-00420 |
| MDR Report Key | 7329973 |
| Date Received | 2018-03-12 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-03-12 |
| 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 |
| 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 | 2018-03-12 |
| Returned To Mfg | 2018-03-08 |
| Model Number | UHI-4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-12 |