Evidence map›Paper›PMID 35991750›Full record

ArticleProceedings (Baylor University. Medical Center)2022

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE.

Esther Lee, Amir Elzomor, Sameh Boulos, Olivia Silva, Luke J Pasick, Daniel A Benito, Jane Tong, Philip Zapanta, Arjun S Joshi, Joseph F Goodman and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Proceedings (Baylor University. Medical Center), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Esther LeeDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Amir ElzomorDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Sameh BoulosDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Olivia SilvaDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Luke J PasickDepartment of Otolaryngology-Head and Neck Surgery, University of Miami Miller School of Medicine, Miami, Florida.
Daniel A BenitoDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Jane TongDepartment of Otolaryngology-Head and Neck Surgery, University of Maryland School of Medicine, Baltimore, Maryland.
Philip ZapantaDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Arjun S JoshiDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Joseph F GoodmanDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Punam G ThakkarDivision of Otolaryngology-Head and Neck Surgery, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The pulse-electron avalanche knife (PEAK) PlasmaBlade 3.0 and 4.0 (Medtronic, Minneapolis, MN) is an electrosurgical technology that is widely used in surgery. Our study aimed to summarize device malfunctions, patient injuries, and interventions related to PEAK PlasmaBlade 3.0 and 4.0. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of PlasmaBlade adverse events from June 6, 2010, to August 30, 2020. Data were extracted from reports pertaining to PlasmaBlade 3.0 and 4.0. A total of 384 medical device reports were identified, from which 424 adverse events were extracted. Of those, 348 (82.1%) were device malfunctions, 53 (12.5%) were patient injuries, and 23 (5.4%) were operator injuries. Device malfunctions were most frequently caused by delaminated coating (110, 25.9%), followed by ignition or fire (56, 13.2%). Operator injury was most frequently caused by thermal injury (19, 4.5%), followed by laceration (4, 0.9%). Pacemakers (22, 57.9%) were the most common devices causing interference. PEAK PlasmaBlade 3.0 and 4.0 have demonstrated utility during surgeries but are associated with adverse events. Interventions that aim to educate physicians on potential risks may help reduce the incidence of complications. Future studies with standardized reporting protocols are warranted.

Indexed as

Adverse eventsMAUDEpatient safetyPlasmaBlade

Identifiers

PMID35991750
PMCPMC9373757

What OpenQuestion holds

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Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.