Microdebrider complications in sinus surgery: Analysis of the openFDA database

Abstract Objective Functional 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. Methods The 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. Results A 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%). Conclusions Microdebrider 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.


Highlights
• The openFDA database was queried for adverse events related to microdebrider use over a 20-year period.
• Analysis of the openFDA database demonstrates that microdebrider device failures are rare, and in over 90% of cases do not result in patient harm.
• The most common reasons for microdebrider device failure are overheating and device separation, and are likely related to component wear after repeated use or improper maintenance.

INTRODUCTION
Functional endoscopic sinus surgery (FESS) is one of the most common procedures performed by otolaryngologists, and over 250,000 sinus operations are performed annually in the United States. 1 Over the past 20 years, microdebriders have become an essential tool in the Otolaryngologist's armamentarium.The combination of suction with a rotating blade makes ablating nasal polyps and other sinonasal soft tissue extremely efficient. 2Today, several companies offer microdebrider instruments for surgical use.
It is imperative that surgeons understand the possible adverse events related to the use of their surgical tools.[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/).
5][16][17][18][19] Using openFDA, we sought to investigate and characterize adverse events related to microdebrider use and device malfunction in sinus surgery.Specifically, we identified manufacturers, device models, and types of malfunctions and adverse events related to microdebrider use.

MATERIALS AND METHODS
OpenFDA is a tool that retrieves and formats data from several FDA postmarket surveillance data sources: FDA Adverse Reporting System, Manufacturer and User Facility Device Experience (MAUDE), Recall Enterprise System, and others.Medical device manufacturers, user facilities, and importers are required to submit adverse event reports to MAUDE per FDA regulation 21 CFR Part 803.Health professionals, caregivers, and patients can also voluntarily submit reports. 16e OpenFDA database was queried for any adverse events while using microdebrider in otolaryngologic surgery from January 1, 2000 to November 1, 2020.Device events were obtained based on the criteria listed in Table 1 The acquired data set was exported into Microsoft Excel (Microsoft Corporation) and manually verified for accuracy.An adverse event was defined as an event that led to patient harm, provider harm, surgical delay, device failure without harm or delay, or a near miss.The narrative section of the event report was used to categorize the event.Events that did not fit these criteria were excluded from the sample.The type of failure, aspect of the device that failed, device brand, and type of patient harm were noted.Reported events that were not categorized as adverse events were also reviewed by these criteria.No individual patient data were collected during the completion of this project.This study was deemed exempt from institutional review board review given that no human subjects were involved, and all medical device adverse event information used is in the public domain.

RESULTS
A total of 693 adverse events were identified.These events were reviewed to ensure that they involved true adverse events involving microdebrider use in sinus surgery, and 641 events were ultimately included in our study.Of the 52 cases rejected, the most common reasons featured cases not involving microdebriders (n = 28), duplicate event submissions (n = 18), cases involving usage of a microdebrider for nonotolaryngologic purposes (n = 3), and cases due to surgeon error unrelated to the usage of the microdebrider (n = 2).
The 641 events included in our analysis featured a variety of microdebrider handpieces, blades, and burr attachments (Table 2).The most common microdebrider reported in the database involved the SABA ET AL.
Adverse events were then categorized based on the level of harm to the patient or healthcare provider.Of the 641 adverse events, 579 (90.3%) involved cases of device failure without patient harm.A total of 35 events (5.5%) involved device failure, resulting in a brief (<30 min) or unspecified but assumed surgical time delay.Twenty-four events (3.7%) involved actual harm to the patient, defined as a temporary or permanent injury such as increased bleeding, undesired tissue trauma, or significant additional anesthesia exposure (>30 min).In two adverse events, the surgeon suffered a temporary injury in the form of an electric shock as the result of a device malfunction.Neither of these incidents resulted in permanent injury to the healthcare provider.
In one near-miss adverse event (0.2%), device overheating resulted in the melting of a portion of the drapes overlying the patient, with no injury to the patient.
In analyzing the 24 events involving true harm to the patient, 18 (75%) involved patient harm due to device malfunction (Table 4).
Notably, five events (20.8%) featured patient harm due to surgeon error with submission report and postoperative device analysis showing no fault in the microdebrider device itself.These involved, T A B L E 1 OpenFDA query criteria and corresponding codes.

Sequelae of microdebrider adverse events
The microdebrider is a commonly used tool in sinus surgery to remove polyps and diseased tissue.OpenFDA is a resource developed in 2013 to create drug and medical device accountability by streamlining the accessibility of publicly available data. 16In this study, we identify 641 adverse events associated with microdebrider use during FESS in the openFDA database.The vast majority of these events were not associated with patient or surgeon harm (90.3%).Of the remainder, the most commonly reported complication (5.5%) was a minor case delay (<30 min).In the cases where the patient was directly harmed, the need to reschedule the case after intubation (0.8%), retained foreign body (0.8%), undesired tissue trauma (0.8%), and bleeding (0.3%) were noted.To the best of our knowledge, this is the first report of microdebrider failure rates in FESS.
The advantages of microdebriders are well documented.1][22] Nonetheless, as with any surgical instrument, microdebriders have unique risks and limitations.For instance, disturbances in cardiac monitoring equipment during microdebrider device use have been reported.Patadia et al. 23 noted several false asystolic events during microdebrider use that resulted in an aborted procedure and costly diagnostic testing, ultimately thought to be due to electrical interference from a chassis leak.Other authors have noted apparent ventricular tachycardia on intraoperative electrocardiograms, also thought to be to electrical interference. 24,25While not directly noted in our data set, it is possible that electrocardiogram malfunction could be the cause of case rescheduling after intubation in some patients, although these details were not available in the openFDA data set.

Etiology of microdebrider device failure
The most common reasons for failure overall were overheating and device separation.Presumably, these issues are related to component wear after repeated use or improper maintenance.It is unknown from the data how long the affected devices had been in use and if there had been prior issues with the device; unsuccessful attempts were made to obtain recommendations from device manufacturers regarding device longevity and indications for replacement.Naturally, appropriate device maintenance could prevent some of these issues, although it is difficult to make generalizations without more granular data.In the cases of patient harm, the failures occurred in a similar pattern.Retained foreign body implies some amount of device separation and thermal injury implies device overheating.
Fortunately, while the rate of device failure is low, the fact that

Limitations
There are a number of limitations to this study.The data are retrospective and limited to the reported information in the openFDA database.Although the manufacturers are required to report device failures, individual surgeons report voluntarily to the openFDA.
Unfamiliarity with the database and lack of time to report failures act as potential confounders.Similarly, there is often a lack of details regarding complications, making it difficult to make generalizations about the data.Although it has been estimated that over 250,000 sinus surgeries are performed in the United States every year, it is unknown how many cases involve microdebriders, and thus overall rates of device failure on a per-case basis are difficult to estimate. 1

CONCLUSION
Although microdebriders are very safe instruments, device failures occur and most commonly involve overheating of the instrument and component separation.We suggest examining the instrument components during assembly, which could detect issues and help prevent patient adverse events.
devices generally fail due to component separation or overheating implies that safety measures can decrease adverse events.Troubleshooting techniques may depend on the manufacturer and model type of the device employed; however, some general principles related to patient safety and device care are shared by multiple microdebrider devices.Microdebrider devices should be briefly inspected and tested outside of the patient at the desired speed before in vivo use.Attention to the microdebrider for wear and corrosion, attachment of the bit to the handpiece, and test of the function of the instrument during assembly would be helpful to prevent patient injury.The use of accessories such as certain blades may cause "wobble" of the tip, suggesting that the accessory is improperly seated within the device and should be corrected before use.Commonly, the blade opening of the device may become obstructed by soft tissue intraoperatively.In this instance, the tip of the device should be placed in sterile water with a suction connected to the handpiece to remove the obstruction.Care should be taken to not submerge the hub of the device.If continued difficulties are encountered, the device should be evaluated or replaced.Overall, the microdebrider failure rate is low and there is no need for additional process controls.
Device involved in the adverse event.Type of device failure.Type of patient harm event.