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Olympus Empower H100
No active recall
Manufacturer: Olympus · FDA product code: GEX · Category: Powered Laser Surgical Instrument
Severity Snapshot
70 total reports2019-04 – 2024-03 date range0% physician / facility reported100% manufacturer reported2 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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