MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[132764076]
The subject uhi-4 was not returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject uhi-4 to identify the root cause of this failure phenomenon when omsc receives it. The exact cause of the reported event could not be conclusively determined at this time. The uhi-4 instruction manual states the corresponding method when there is an abnormality for the device. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[132764077]
During unspecified laparoscopic surgery, the subject uhi-4 could not insufflate co2 into the patient's body. The physician changed the procedure to the open surgery and completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-00823 |
| MDR Report Key | 8234781 |
| Date Received | 2019-01-10 |
| Date of Report | 2019-03-15 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-01-10 |
| 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 | 3 |
| Brand Name | HIGH FLOW INSUFFLATION UNIT |
| Generic Name | HIGH FLOW INSUFFLATION UNIT |
| Product Code | FCX |
| Date Received | 2019-01-10 |
| Model Number | UHI-4 |
| Device Availability | N |
| 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 | 1. Other | 2019-01-10 |