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ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10374)

ENDOWRIST;DAVINCI SI Adverse Event — Malfunction (MDR 2955842-2020-10374) 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.

DeviceENDOWRIST;DAVINCI SI
Generic namePERMANENT CAUTERY HOOK
ManufacturerINTUITIVE SURGICAL, INC
Report number2955842-2020-10374
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceOTHER
NarrativeINTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS REPORTED THAT THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE DISLODGED FROM THE CONDUCTOR CAP AND THE WIRE WAS EXPOSED ON THE OUTSIDE OF THE YAW PULLEY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE CONDUCTOR CAP WAS PROPERLY SEATED WITHIN
SourceopenFDA MAUDE (device adverse events)

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