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Intuitive Surgical Mega Needle Driver
No active recall
Manufacturer: Intuitive Surgical · FDA product code: NAY · Category: System, Surgical, Computer Controlled Instrument
Severity Snapshot
442 total reports2009-10 – 2024-09 date range1.4% physician / facility reported98.6% manufacturer reported3 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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