MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[93499821]
The referenced uhi-4 was returned to olympus medical systems corp. (omsc) for evaluation. The evaluation could confirm the user? S report, and found that the pressure sensor of the uhi-4 was damaged. Therefore the uhi-4 could not operate properly, and it caused the alarming and inoperability. The cause of the damage of the pressure sensor cannot be conclusively determined, however there was the possibility that the pressure sensor broke accidentally. Omsc stated the counter measures against abnormalities of uhi-4 in the instruction manual of uhi-4. 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
[93499822]
Olympus was informed that before the laparoscopic cholecystectomy, the uhi-4 alerted and could not operate. The patient was already under anesthesia. The facility changed the referenced 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 | 8010047-2017-01800 |
| MDR Report Key | 7040035 |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2016-01-13 |
| Date Added to Maude | 2017-11-17 |
| 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 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 | 2017-11-17 |
| Model Number | UHI-4 |
| Device Availability | * |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |