MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-13 for OLYMPUS EVIS EXERA II XENON LIGHT SOURCE CLV-180 NA manufactured by Olympus Medical Systems Corporation.
[16489211]
The light source and power cord were returned to olympus for evaluation. The evaluation confirmed the user's report that the system would not power on. Additionally, the lamp cover was found to be dented at the knob. There was a brown discoloration at the female connector of the power cord, indicative of a high-temperature event. The rear panel fuses were found to be open, and the converter unit was damaged and melted at the fuse box. The fuses and converter unit were replaced, and the light source passed all functional and electrical tests. The device was repaired and returned to the user facility. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[16641014]
The user facility reported that the light source powered off during the start of a diagnostic colonoscopy and could not be restarted. The users attempted to replace the power cord without success. Brown discoloration was reportedly observed on the end of the power cord that had been connected to the rear panel of the device. The user facility reported that the users withdrew the unidentified endoscope from the pt, and transferred the pt to a different room to complete the procedure. The procedure was said to have been completed with a different, but similar video cart and the same endoscope. There was no pt injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2010-00072 |
| MDR Report Key | 1661491 |
| Report Source | 05,06 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-03-16 |
| Date of Event | 2010-03-16 |
| Date Mfgr Received | 2010-03-16 |
| Date Added to Maude | 2010-12-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS EVIS EXERA II XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | LYK |
| Date Received | 2010-04-13 |
| Model Number | CLV-180 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-13 |