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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
2023-09-22Z-0075-2024Class IOpen, ClassifiedThere have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.Distribution: US Nationwide distribution.3136 unitsclearance family
Regulatory clearances
  • 510(k)K122180Substantially equivalent (SESE) · 2012-11-13clearance family

Predicate lineage

K122180

Cited as predicate by: K161554, K170784, K243527

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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