VISERA ELITE II VIDEO SYSTEM CENTER Adverse Event — Malfunction (MDR 8010047-2020-02403)
VISERA ELITE II VIDEO SYSTEM CENTER Adverse Event — Malfunction (MDR 8010047-2020-02403) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VISERA ELITE II VIDEO SYSTEM CENTER; Generic name: VIDEO SYSTEM CENTER; Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP..
| Device | VISERA ELITE II VIDEO SYSTEM CENTER |
|---|---|
| Generic name | VIDEO SYSTEM CENTER |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Report number | 8010047-2020-02403 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED; -OMSC COULD NOT REPRODUCE THE REPORTED PHENOMENON WHICH WAS THAT THE ENDOSCOPIC IMAGE DISAPPEARED. -OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIR |
| Source | openFDA MAUDE (device adverse events) |
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