ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10369)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10369) 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 | 2955842-2020-10369 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "ARCING ISSUE." THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE OF THE CONDUCTOR WIRE¿S INSULATION. THE DISTAL CLEVIS EAR WAS CUT TO INSPECT |
| Source | openFDA MAUDE (device adverse events) |
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