MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-07-26 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[50515180]
The subject device was returned to olympus for investigation but the phenomenon was not reproduced so far. Olympus will perform further investigation to determine the cause of this phenomenon. 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
[50515181]
During the unspecified procedure, the examination lamp of the subject device went off and the emergency lamp did not started up. The user completed the procedure using the same clv-190 because after the user turned on the subject device several times, the subject device worked properly. There was no report of the patient injury in this event
Patient Sequence No: 1, Text Type: D, B5
[55250809]
This is a supplemental report for mfr report #8010047-2016-00988 to provide device evaluation results. Olympus checked following items of the subject device, and there was no abnormality found. Olympus checked the function of the subject device. Olympus checked the state of the connection of the harness inside the subject device. Olympus checked that there was no abnormality with long operation of the subject device. Olympus checked that there was no abnormality at the subject device with vibration. Additionally, there was dust inside the subject device. Olympus could not identify the cause of the failure of the emergency lamp. Olympus think the subject device did not work properly temporarily by some cause. It is considered accidental failure since the similar condition of clv-190 doesn't occur the past 3 years. Olympus stated the appropriate handling of the subject device in the instruction manual when the subject device had abnormalities. 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
| Report Number | 8010047-2016-00988 |
| MDR Report Key | 5824688 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-26 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2016-07-27 |
| Device Manufacturer Date | 2012-06-08 |
| Date Added to Maude | 2016-07-26 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SH, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 42 6425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-07-26 |
| Returned To Mfg | 2016-07-13 |
| Model Number | CLV-190 |
| Operator | HEALTH PROFESSIONAL |
| 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-SH, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-26 |