MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-11 for EVIS LUCERA XENON LIGHT SOURCE CLV-260SL manufactured by Olympus Medical Systems Corp..
[108643098]
Since the subject device clv-260sl was not returned to olympus medical systems corp. (omsc), the investigation has not been performed for the subject device yet. Confirming the manufacturing record of the clv-260sl, omsc did not find any irregularities in such device. The instructions for use of the clv-260sl includes warnings or cautions describing how to handle the subject device when any irregularity is observed. Omsc has neither performed any investigation into the clv-260l yet nor identified the cause. Omsc estimates that the cause of the subject event is applicable to one of the following: age deterioration of the power supply unit etc. , causes a shortage of the power supply voltage for lighting the lamp; or adhesion of dust to the light guide lens or the deterioration of optical system performance causes the shortage of light quantity.
Patient Sequence No: 1, Text Type: N, H10
[108643099]
According to a report from an user, the light emitted from clv-260sl got dim under an unspecified condition. After the examination lamp was replaced, the light got dim again during the next unspecified procedure. The user decided to discontinue the unspecified procedure. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00817 |
| MDR Report Key | 7505823 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-04-16 |
| Date Added to Maude | 2018-05-11 |
| 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 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 LUCERA XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-05-11 |
| Model Number | CLV-260SL |
| 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 | 2018-05-11 |