ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10372)
ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10372) 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 | 2955842-2020-10372 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE REPORTED COMPLAINT. THE PCH MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE FOLLOWING WAS FOUND DURING THE DEVICE EVALUATION, BUT IS NOT RELATED TO THE INITIALLY REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO H |
| Source | openFDA MAUDE (device adverse events) |
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