ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10392)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10392) 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 | 2955842-2020-10392 |
| 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 INSTRUMENT AND PERFORMED DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "BENT WIRE AT THE END." THE 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 ELE |
| Source | openFDA MAUDE (device adverse events) |
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