ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10356)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10356) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: PERMANENT CAUTERY HOOK; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | PERMANENT CAUTERY HOOK |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10356 |
| 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 HOOK (PCH) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE PCH INSTRUMENT WAS FOUND TO HAVE THE CONDUCTOR WIRE WITH DAMAGED INSULATION. THERMAL DAMAGE WAS OBSERVED ON THE MONOPOLAR YAW PULLEY. THE PCH INSTRUMENT WAS FOUND TO HAVE BOTH THE DISTAL CLEVIS AND IDLER PULLE |
| Source | openFDA MAUDE (device adverse events) |
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