ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10363)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10363) 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 | 2955842-2020-10363 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE THAT ¿ENERGY COULD NOT BE APPLIED TO THE INSTRUMENT EVEN AFTER CHANGING ENERGY CABLES.¿ THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END AND FAILED ELECTRICAL CONTINUITY TEST. FA |
| Source | openFDA MAUDE (device adverse events) |
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