ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10393)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10393) 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 | 2955842-2020-10393 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE. THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY. THERE WAS NO DAMAGE FOUND TO THE CONDUCTOR WIRE AND ELECTRICAL CONTINUITY PASSED. A LOG REVIEW WAS CONDUCTED, WHICH R |
| Source | openFDA MAUDE (device adverse events) |
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