MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for EVIS LUCERA ELITE XENON LIGHT SOURCE CLV-290SL manufactured by Olympus Medical Systems Corp..
[118557881]
The subject clv-290sl was not returned to olympus medical systems corp. (omsc). The user will not return the subject clv-290sl. The clv-290sl instruction manual states the corresponding method when there is an abnormality for the device. 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
[118557882]
The user used the subject clv-290sl and the unspecified monitor in the unspecified procedure. During the procedure, the color of the image displayed on the monitor turned green. The user replaced the subject clv-290sl with the similar device and completed the procedure. There was no report of the patient's injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01650 |
| MDR Report Key | 7817455 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-08-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| 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 | 0 |
| Brand Name | EVIS LUCERA ELITE XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-08-27 |
| Model Number | CLV-290SL |
| 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 | 2018-08-27 |