MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-22 for ENDOSCOPIC CO6 REGULATION UNIT UCR manufactured by Olympus Medical Systems Corp..
[78126596]
The facility has no plan to return the referenced ucr to olympus medical systems corp. (omsc) for evaluation, therefore omsc cannot evaluate the ucr. However, on (b)(6) 2017, the olympus field service engineer confirmed that all ucrs (including the referenced the ucr) did not have any problem as routine inspection. Also, prior to use of the procedure, the facility checked the referenced ucr and found the no problem. Also the physician stated that during the procedure there was not any defect of the devices, and the facility was continuing to use the ucr. Therefore the referenced ucr had no malfunction. The exact cause of the reported event could not be conclusively determined at this time. However there is the possibility of this phenomenon is attributed to the patient? S condition. 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
[78126597]
The patient had undergone the ileal conduit diversion as the urinary diversion after the total cystectomy. The patient had evidence of anemia, and the anastomotic hemorrhage from ileum and/or stoma was suspected as the cause of anemia. Therefore the emergency endoscopy was performed in combination with the ucr. During the endoscopy with inserting the endoscope from the patient? S stoma, the patient experienced a drop in blood pressure and then fell into critical condition. A few days after, the patient deceased. According to the result of the autopsy of the patient, there were air emboli in the kidney and the brain, and also the subdural hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00764 |
| MDR Report Key | 6659470 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2017-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | ENDOSCOPIC CO6 REGULATION UNIT |
| Generic Name | CO2 REGULATION UNIT |
| Product Code | FCX |
| Date Received | 2017-06-22 |
| Model Number | UCR |
| Operator | HEALTH PROFESSIONAL |
| 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. Death | 2017-06-22 |