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Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study
- Source :
- American journal of otolaryngology. 42(1)
- Publication Year :
- 2020
-
Abstract
- Purpose 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. Materials and methods 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. Results 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%]). Conclusions 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.
- Subjects :
- Male
medicine.medical_specialty
medicine.medical_treatment
Electrosurgery
Hemorrhage
Risk Assessment
Food and drug administration
Adenoidectomy
03 medical and health sciences
Patient safety
0302 clinical medicine
medicine
Humans
User Facility
030223 otorhinolaryngology
Adverse effect
Intraoperative Complications
Health Education
Tonsillectomy
business.industry
Surgical Instruments
Surgery
Otorhinolaryngology
030220 oncology & carcinogenesis
Head and neck surgery
Equipment Failure
Female
Patient Safety
business
Burns
Patient education
Subjects
Details
- ISSN :
- 1532818X
- Volume :
- 42
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- American journal of otolaryngology
- Accession number :
- edsair.doi.dedup.....7944c692b0b8603cad3a15b02cab9cb8