MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[89806035]
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
[89806036]
The emergency lamp of the subject clv-s190 ignited during unspecified procedure. The user replaced the endoscopic system including the subject clv-s190 with unspecified endoscopic system made by another company 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 | 8010047-2017-01489 |
| MDR Report Key | 6957257 |
| Date Received | 2017-10-18 |
| Date of Report | 2017-11-21 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-10-18 |
| 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 | NWB |
| Date Received | 2017-10-18 |
| Model Number | CLV-S190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Brand Name | VISERA ELITE XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-10-18 |
| Returned To Mfg | 2017-10-17 |
| Model Number | CLV-S190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-18 |