MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[67133471]
The subject clv-190 was returned to olympus for investigation. Now investigation is ongoing. The exact cause of the reported event could not be conclusively determined at this time. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[67133472]
During the unspecified procedure with clv-190, the examination lamp of the subject device went off and the emergency lamp started up. When the technician arrived the examination lamp have exploded and there was internal damage of the subject device. The user facility replaced the subject clv-190 with another unspecified similar device and completed the procedure. There was no report of the patient injury other than replacing the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00141 |
| MDR Report Key | 6310155 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-02-08 |
| 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 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 | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-02-08 |
| Returned To Mfg | 2017-01-24 |
| Model Number | CLV-190 |
| 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 | 2017-02-08 |