MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-07 for HIGH FLOW INSUFFLATION UNIT UHI-4 manufactured by Olympus Medical Systems Corp..
[85087565]
The referenced uhi-4 was not returned to olympus medical systems corp. (omsc) for evaluation, therefore omsc could not evaluate the uhi-4. In the hernia repair procedure, the facility stated that the causes of this phenomenon were attributed to the incorrect insertion of the surgical device into the patient, large patient and the prolonged procedure than usual. Also, the facility stated that the cause of this phenomenon was not attributed to the referenced uhi-4. The staff of olympus keymed(okm) visited the facility and checked the usage of the referenced uhi-4, they found that the facility did not confirm the setting pressure of the uhi-4 before the procedure, and used it with the setting pressure of the previous procedure despite the pressure setting should be set according to the type of the surgery. Furthermore, according to the literature, subcutaneous emphysema is known as common complication that while insufflation of an abdominal cavity. The reported phenomenon is thought of as common complication of abdominal insufflation with incorrect usage of the device. The uhi-4 instruction manual states the notice for the subcutaneous emphysema and appropriately handling of the device. Okm is scheduled to retrain the facility staffs. There were no further details provided. If significant additional information is received, this report will be supplemented. This report is 1 of 3.
Patient Sequence No: 1, Text Type: N, H10
[85087566]
Olympus was informed that since (b)(6) 2017, three patients suffered subcutaneous emphysema during the laparoscopic procedures. One case was the hernia repair, two cases were unspecified gynecological surgery. The patients required medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01301 |
| MDR Report Key | 6847556 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-07 |
| Date of Report | 2018-02-09 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2017-09-07 |
| 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 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 | 3 |
| Brand Name | HIGH FLOW INSUFFLATION UNIT |
| Generic Name | HIGH FLOW INSUFFLATION UNIT |
| Product Code | FCX |
| Date Received | 2017-09-07 |
| 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 | 1. Other | 2017-09-07 |