2024
Soft tissue injury events associated with neural integrity monitoring endotracheal tubes: A MAUDE database analysis
Salib A, Melero Pardo A, Lerner M. Soft tissue injury events associated with neural integrity monitoring endotracheal tubes: A MAUDE database analysis. American Journal Of Otolaryngology 2024, 45: 104233. PMID: 38417263, DOI: 10.1016/j.amjoto.2024.104233.Peer-Reviewed Original ResearchNeural integrity monitorSoft tissue injuriesAdverse eventsEndotracheal tubeTissue injuryRisk of nerve injuryDevice-related adverse eventsReports of adverse eventsTissue injury eventsSurgical decision-makingFood and Drug AdministrationRecurrent laryngeal nerveInjury typeProcess of intubationInjury eventsPatient injuryStandard endotracheal tubeNeck surgeryIncreased technical skillNerve injuryVocal fold paralysisSurgical interventionIntraoperative monitoringSuture repairLaryngeal nerve
2023
Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis
Narwani V, Dacey S, Lerner M. Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis. Otolaryngology 2023, 170: 391-395. PMID: 37622490, DOI: 10.1002/ohn.501.Peer-Reviewed Original ResearchAdverse eventsPercutaneous tracheostomyMAUDE databasePatient-related adverse eventsRetrospective cross-sectional studyDevice-related adverse eventsDevice malfunctionMAUDE Database AnalysisTracheostomy tube obstructionPatient-related factorsRare adverse eventsUser Facility Device Experience (MAUDE) databaseCross-sectional studyBalloon malfunctionDevice-related failuresTracheostomy complicationsTube obstructionOpen tracheostomyCase reportDevice complicationsCuff deflationTracheostomyLine malfunctionPatient injuryFDA MAUDE database