MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[91834627]
The subject clv-s190 will be returned to olympus medical systems corp. (omsc) for the evaluation. Omsc continues to investigate this event. Clv-s190 instruction manual states the corresponding method in case of an abnormality. There were no further details provided. If significant additional information is found, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[91834628]
The emergency lamp of the subject clv-s190 ignited during unspecified procedure. The user replaced the subject clv-s190 with another clv-s190 and completed the procedure. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
[94553266]
The subject clv-s190 was returned to olympus medical systems corp. (omsc) for the evaluation. Omsc performed the following, however this phenomenon was not reproduced. -it was repeated 100 times that the subject clv-s190 was turned on and turned off. -the subject clv-s190 was operated for 3 hours. Omsc checked the subject clv-s190 and the following found. -the light quantity of the xenon lamp in the subject clv-s190 was lower than the xenon lamp owned by omsc. -the light quantity became normal after the subject clv-s190 was combined with the xenon lamp owned by omsc. -the xenon lamp in the subject clv-s190 had the small crack on the surface. Omsc surmised that this phenomenon might have occurred by following. -the light quantity of the xenon lamp in the subject clv-s190 became lower because the xenon gas in the xenon lamp leaked from the crack on the surface. The light quantity of the xenon lamp was equivalent to the emergency lamp. The user recognized that the emergency lamp ignited. There were no further details provided. If significant additional information is found, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[140016878]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2017-01709 |
| MDR Report Key | 7016583 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2017-11-09 |
| 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 KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VISERA ELITE XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-11-09 |
| Model Number | CLV-S190 |
| 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 CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-09 |