ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10352)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10352) 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 | 2955842-2020-10352 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | (B)(4). INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE PCH INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE DISLODGED FROM THE CONDUCTOR CAP AND IT WAS EXPOSED ON THE OUTSIDE OF THE YAW PULLEY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. IT W |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →