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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2026-01-16Z-1354-2026Class IOpen, ClassifiedIssue with software algorithm which may lead to overpressure events.Distribution: Nationwide distribution485 unitsclearance family
Regulatory clearances

    Predicate lineage

    K014166

    Cited as predicate by: K110294

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2022-12-12WLWarning LetterOlympus Medical Systems Corporation—
    2022-09-09OAIOfficial action indicatedOlympus Medical Systems Corporation1
    2018-03-09WLWarning LetterOlympus Medical Systems Corporation—
    2015-04-24OAIOfficial action indicatedOlympus Medical Systems Corporation2
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