Microdebrider complications in laryngologic and airway surgery

Howell, Rebecca J.; Solowski, Nancy; Belafsky, Peter C.; Courey, Mark; Meratı, Albert L.; Rosen, Clark A.; Weinberger, Paul M.; Postma, Gregory N.

doi:10.1002/lary.24842

Cited by 9 publications

(7 citation statements)

References 10 publications

(14 reference statements)

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“…However, since the microdebrider is a powered instrument that is frequently used in such confined spaces, usage can result in patient harm with user error or device malfunction. Several studies have identified complications of microdebrider use within the head and neck, but conclusions have largely been derived from single institutional data and focused on a single head and neck subsite 8–10 …”

Section: Figurementioning

confidence: 99%

“…Several studies have identified complications of microdebrider use within the head and neck, but conclusions have largely been derived from single institutional data and focused on a single head and neck subsite. [8][9][10] Our study utilized the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database to report the incidence and type of complications that occur with microdebrider usage in otolaryngologic surgeries. The MAUDE Database is an online resource that compiles the adverse events of medical devices.…”

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confidence: 99%

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Complications Associated with Microdebriders in Otolaryngology Procedures from 2011 to 2021: A MAUDE Study

Magge,

Lee,

Shaver

et al. 2023

OTO Open

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ObjectiveThe microdebrider is a powered surgical instrument that is widely used in the field of otolaryngology. We aim to identify the type and frequency of device malfunctions, patient complications, and subsequent interventions related to the use of microdebriders.Study DesignCross‐sectional analysis.SettingThe US Food and Drug Administration (FDA) 2011 to 2021 Manufacturer and User Facility Device Experience (MAUDE) database.MethodsThe MAUDE database was queried for reports of “microdebrider,” with adverse events selected that pertained to usage in head and neck surgeries from January 1, 2011 to December 31, 2021.ResultsThere were 282 adverse events in 267 individual medical device reports (MDR). Although the majority of the reports did not specify the specific operation, endoscopic sinus surgery was the most common reported procedure (89, 33.3%). The most common cause of device malfunction was due to a broken piece (120, 48.2%) followed by overheating of the microdebrider motor (78, 31.3%). Of the reports which specified patient injury, the most commonly reported was “unintentional tissue damage,” (10, 32.3%).ConclusionThe microdebrider has demonstrated utility within the field of otolaryngology, but is not without risk of malfunction that can cause patient injury. By understanding possible risks of microdebrider usage, including tissue damage, burns, and bleeds caused by device malfunction or operator error, physicians can be better prepared to address complications and educate patients.

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Section: Figurementioning

confidence: 99%

mentioning

confidence: 99%

Complications Associated with Microdebriders in Otolaryngology Procedures from 2011 to 2021: A MAUDE Study

Magge,

Lee,

Shaver

et al. 2023

OTO Open

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“…Much has been published about risks and complications related to sinus surgery, especially given the proximity of the paranasal sinuses to the orbit and brain 3–9 . However, complications specifically related to microdebrider use have been much less commonly explored, and to our knowledge, there are no research articles characterizing patterns of microdebrider device malfunction 10–13 …”

Section: Introductionmentioning

confidence: 99%

“…[3][4][5][6][7][8][9] However, complications specifically related to microdebrider use have been much less commonly explored, and to our knowledge, there are no research articles characterizing patterns of microdebrider device malfunction. [10][11][12][13] In 2014, the US Food and Drug Administration (FDA) launched openFDA, an open-source database that provides access to publicly available medical device reports, enforcement reports, and drug event reports (https://open.fda.gov/about/).…”

Section: Introductionmentioning

confidence: 99%

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Microdebrider complications in sinus surgery: Analysis of the openFDA database

Saba

Hoerter

Chang

et al. 2023

World j. otorhinolaryngol.-head neck surg.

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ObjectiveFunctional endoscopic sinus surgery is a commonly performed otolaryngologic procedure that often uses the microdebrider device for tissue removal. Given the ubiquitous nature of the instrument, we sought to better define the patterns of device failure using the postmarket surveillance openFDA database.MethodsThe openFDA database was queried for all microdebrider‐related adverse events from January 1, 2000 to November 1, 2020. Descriptive information on the nature of device failure and any associated patient injury was compiled. Reports not directly related to device failure were excluded from the analysis.ResultsA total of 641 events were included in the analysis. The most common device failure was overheating (n = 348, 54.3%), followed by material separation (n = 173, 27%), and inconsistent device activation (n = 52, 8.1%). Of the reported events, the vast majority did not result in patient harm (n = 579, 90.3%). On review of the remaining cases, only 24 events (3.7%) resulted in true harm to the patient, defined as a temporary or permanent injury or >30 min of additional anesthesia time. Of these cases, the need to reschedule surgical cases (n = 5, 0.8%), retained foreign body (n = 5, 0.8%), and thermal tissue injury (n = 3,0.5%) were the most common. Five patients suffered an injury due to surgeon error unrelated to device malfunction (n = 5, 0.8%).ConclusionsMicrodebrider device failures are extremely rare. When they do occur, less than 10% result in patient harm. In cases of patient harm related to microdebrider failure, preoperative testing of the device before use could prevent many of the reported malfunctions.

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