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Olympus Cystourethroscope Standard Obturator

No active recall

Manufacturer: Olympus  · FDA product code: FEC  · Category: Obturator, For Endoscope

Severity Snapshot

11 total reports2013-102022-09 date range9.1% physician / facility reported90.9% manufacturer reported4 SKU variants

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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