EVIS EXERA III XENON LIGHT SOURCE Adverse Event — Malfunction (MDR 8010047-2020-02400)
EVIS EXERA III XENON LIGHT SOURCE Adverse Event — Malfunction (MDR 8010047-2020-02400) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EVIS EXERA III XENON LIGHT SOURCE; Generic name: XENON LIGHT SOURCE; Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP..
| Device | EVIS EXERA III XENON LIGHT SOURCE |
|---|---|
| Generic name | XENON LIGHT SOURCE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Report number | 8010047-2020-02400 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | OTHER, USER FACILITY |
| Narrative | THE DEVICE IS NOT RETURNED. AS SUCH, AN ACTUAL DEVICE EVALUATION IS NOT PERFORMED. AN EVALUATION IS DONE BASED ON HISTORICAL RECORDS. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT DEVICE HAS NO ABNORMALITIES, SPECIAL ADOPTION, OR VARIATIONS IN MANUFACTURING. THE REPORTED ISSUE FOR THE DEVICE WAS AN E200 ERROR DISPLAYED ON T |
| Source | openFDA MAUDE (device adverse events) |
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