VISERA CYSTO-NEPHRO VIDEOSCOPE Adverse Event — Malfunction (MDR 8010047-2020-02409)
VISERA CYSTO-NEPHRO VIDEOSCOPE Adverse Event — Malfunction (MDR 8010047-2020-02409) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VISERA CYSTO-NEPHRO VIDEOSCOPE; Generic name: CYSTO-NEPHRO VIDEOSCOPE; Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP..
| Device | VISERA CYSTO-NEPHRO VIDEOSCOPE |
|---|---|
| Generic name | CYSTO-NEPHRO VIDEOSCOPE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Report number | 8010047-2020-02409 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | THE DAMAGED DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR REPAIR AND EVALUATION. BASED ON THE INFORMATION PROVIDED TO OLYMPUS BY THE USER FACILITY, THE CAUSE OF THE DAMAGE TO THE SCOPE HAS BEEN ASSIGNED TO THE USER DUE TO FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE REPROCESSING INSTRUCTIONS. THE USER FACILITY STATED THE CAP WAS NOT ATTACHED DURING STERILIZATION. A STERILIZER (UNKNOWN MANUFACTURER, MO |
| Source | openFDA MAUDE (device adverse events) |
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