ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10381)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10381) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST;DAVINCI SI; Generic name: PERMANENT CAUTERY HOOK; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST;DAVINCI SI |
|---|---|
| Generic name | PERMANENT CAUTERY HOOK |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10381 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | 4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED/CONFIRMED THE REPORTED ISSUE AND FOUND THE PERMANENT CAUTERY HOOK TO HAVE A SEGMENT OF THE CONDUCTOR WIRE DISLODGED FROM THE CONDUCTOR WIRE CAP. THE CONDUCTOR WIRE WAS EXPOSED OUTSIDE OF THE MONOPOLAR YAW PULLEY AS A RESULT. THE INSTRUMENT PASSED AN EL |
| Source | openFDA MAUDE (device adverse events) |
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