Journal article
Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study
American journal of otolaryngology, v 42(1), 102826
Jan 2021
PMID: 33220495
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The pulsed-electron avalanche knife (PEAK) PlasmaBlade TnA (Medtronic, n.d.) is a relatively new electrosurgical technology that is used widely in head and neck surgery (Medtronic Manuals, n.d.). This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to PEAK PlasmaBlade TnA during tonsillectomy and adenoidectomy.
The US Food and Drug Administration's Manufacture and User Facility Device Experience database was queried for reports of PlasmaBlade TnA adverse events from June 6, 2009, to August 30, 2020. Data were extracted from reports pertaining to tonsillectomy with or without adenoidectomy.
128 reports were identified, from which 163 adverse events were extracted. Of these, 23 (14.6%) were related to patients, and 140 (85.4%) were related to device malfunction. The most frequently reported patient-related adverse event was a burn injury (17 [73.9%]). The most common device malfunctions were dislodgment of device component (39 [27.9%]), followed by tip ignition (32 [22.9%]), damaged tip or wire during operation (28 [20%]), and melted device (24 [17.1%]).
PEAK PlasmaBlade TnA have demonstrated utility in tonsillectomy with or without adenoidectomy but are associated with adverse events. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further study is needed to clarify optimal approaches to education.
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Details
- Title
- Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study
- Creators
- Esther Lee - George Washington UniversityJane Y Tong - Department of Otolaryngology-Head and Neck Surgery, Drexel University College of Medicine, Philadelphia, PA, United States of America. Electronic address: jyt24@drexel.eduLuke J Pasick - Department of Otolaryngology-Head and Neck Surgery, University of Miami Miller School of Medicine, Miami, FL, United States of AmericaDaniel A Benito - Division of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine & Health Sciences, Washington, DC, United States of America. Electronic address: jbenito@gwu.eduArjun Joshi - George Washington UniversityJoseph F Goodman - George Washington UniversityPunam G Thakkar - George Washington University
- Publication Details
- American journal of otolaryngology, v 42(1), 102826
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Otolaryngology (and Head and Neck Surgery)
- Web of Science ID
- WOS:000600420000011
- Scopus ID
- 2-s2.0-85096645880
- Other Identifier
- 991021860749904721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Otorhinolaryngology