VISERA ELITE VIDEO SYSTEM CENTER Adverse Event — Malfunction (MDR 8010047-2020-02394)
VISERA ELITE VIDEO SYSTEM CENTER Adverse Event — Malfunction (MDR 8010047-2020-02394) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VISERA ELITE VIDEO SYSTEM CENTER; Generic name: VIDEO SYSTEM CENTER; Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP..
| Device | VISERA ELITE VIDEO SYSTEM CENTER |
|---|---|
| Generic name | VIDEO SYSTEM CENTER |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Report number | 8010047-2020-02394 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, USER F |
| Narrative | THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE REVIEW OF THE DEVICE HISTORY RECORDS (DHR). THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. THE ROOT CAUSE WAS NOT IDENTIFIED. LIKELY PROBABLE CAUSE WAS THAT WHEN INSER |
| Source | openFDA MAUDE (device adverse events) |
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