ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10395)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10395) 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 | 2955842-2020-10395 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE DISTAL CLEVIS AT THE DISTAL END. THE MONOPOLAR YAW PULLEY ALSO EXHIBITED THERMAL DAMAGE. THERE WAS NEITHER CONDUCTOR WIRE DAMAGE NOR A WELD DEFECT OBSE |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →