NeuroMAUDE
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Intuitive Surgical Harmonic Curved Shears Insert

No active recall

Manufacturer: Intuitive Surgical  · FDA product code: NAY  · Category: System, Surgical, Computer Controlled Instrument

Severity Snapshot

72 total reports2008-032014-02 date range4.2% physician / facility reported95.8% manufacturer reported1 SKU variants

Failure & Consequence Profiles

Top Failure Modes

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Top Patient Outcomes

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Reporting Trend

Annual Reporting Volume

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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.

Reported Events

Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.

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