MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[185749122]
The subject device has not returned for evaluation. As stated on the reported event, the cleaning protocol of the user was changed immediately when the issue happened and to date there was no patient/user harm or injury was reported due to the event. If additional or new information becomes available this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[185749123]
It was reported that the user had sprayed alcohol in the socket of a clv-190 scope which caused fire. It was reported to be a quick flash of fire from an alcohol aerosol in which it went out/disappeared quickly on its own. The issue occurred when the cleaning protocol was being performed in between patient procedure. According to the report the cleaning protocol was changed immediately when the issue happened. This reported incident according to the reporter happened seven years ago and the reported statement from the reporter was made when troubleshooting a video issue during a facility service visit at the unrelated site. There was no patient or user harm and injury reported due to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01905 |
| MDR Report Key | 9904453 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-31 |
| 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 | 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 | 3 |
| Brand Name | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | NWB |
| Date Received | 2020-03-31 |
| Model Number | CLV-190 |
| 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 | 2020-03-31 |