ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10380)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10380) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST;DAVINCI SI; Generic name: PERMANENT CAUTERY SPATULA; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST;DAVINCI SI |
|---|---|
| Generic name | PERMANENT CAUTERY SPATULA |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10380 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | (B)(4). INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY AND DISTAL CLEVIS. THE CONDUCTOR WIRE AND SILICONE POTTING AT THE YAW PULLEY EXIT WERE INTACT AND THERE WAS NO SIGNS OF DAMAGE AROUND |
| Source | openFDA MAUDE (device adverse events) |
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