ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10351)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10351) 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 | 2955842-2020-10351 |
| 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 (FA) COULD NOT CONFIRM NOR REPLICATE THE REPORTED COMPLAINT. A VISUAL INSPECTION DID NOT FIND THERMAL DAMAGE TO THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT, AND NO SIGNS OF ARCING WERE OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED |
| Source | openFDA MAUDE (device adverse events) |
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