ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10367)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10367) 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 | 2955842-2020-10367 |
| 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 CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF ¿WIRES ARE LOOSE". THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE STICKING OUT FROM THE YAW PULLEY. A LOOP OF WIRE IS STICKING OUT SUCH THAT THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE MAIN TUBE. THE I |
| Source | openFDA MAUDE (device adverse events) |
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