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Boston Scientific Lumenis
No active recall
Manufacturer: Boston Scientific · FDA product code: GEX · Category: Powered Laser Surgical Instrument
Severity Snapshot
23 total reports2003-07 – 2024-10 date range100% physician / facility reported0% manufacturer reported5 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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