MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-31 for MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3 manufactured by Olympus Medical Systems Corp..
[66442321]
The subject uces-3 was returned to olympus for evaluation. Olympus checked the subject uces-3, and there was no abnormality of the subject device. There were no further details provided at this time. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[66442322]
During the unspecified laparoscopic surgery, the user facility could not operate devices, because an image of a main monitor and a sub monitor of the endoalpha system disappeared. The user facility replaced the subject system including uces-3 with another unspecified system to complete the procedure. There was no report of the patient injury other than replacing the device. When the subject system was checked after the procedure, there was no abnormality of the subject system. The user facility suspects the subject uces-3 which controls the 2 monitors to display images might have any abnormality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00100 |
| MDR Report Key | 6288864 |
| Date Received | 2017-01-31 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2017-11-13 |
| Device Manufacturer Date | 2010-10-15 |
| Date Added to Maude | 2017-01-31 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICAL CONTROL UNIT FOR ENDOSURGERY |
| Generic Name | SYSTEM INTEGRATION |
| Product Code | ODA |
| Date Received | 2017-01-31 |
| Returned To Mfg | 2017-01-12 |
| Model Number | UCES-3 |
| 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 | 2017-01-31 |