ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10371)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10371) 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 | 2955842-2020-10371 |
| 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 THAT THE INSTRUMENT "WOULD NOT CAUTERIZE." FOR CLARIFICATION THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE WRIST. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST AND THE ENERGY ACTIVATION TE |
| Source | openFDA MAUDE (device adverse events) |
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