Microdebrider complications in sinus surgery:Analysis of the openFDA database  

作　　者：Elias S.Saba Jacob Hoerter Jeremy Chang David W.Chou Chris Xiao Jacob G.Eide Rijul S.Kshirsagar James N.Palmer Nithin D.Adappa 

机构地区：[1]Department of Head and Neck Surgery,Kaiser Permanente Oakland Medical Center,Oakland,California,USA [2]Department of Otorhinolaryngology‐Headand Neck Surgery,Perelman School of Medicine,University of Pennsylvania,Philadelphia,Pennsylvania,USA [3]Department of Otolaryngology‐Head and Neck Surgery,Mount Sinai Medical Center,New York,New York,USA [4]Department of Otorhinolaryngology‐Head and Neck Surgery,University of Pennsylvania,Philadelphia,Pennsylvania,USA

出　　处：《World Journal of Otorhinolaryngology-Head and Neck Surgery》2023年第4期328-332,共5页世界耳鼻咽喉头颈外科杂志（英文）

摘　　要：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.

关 键 词：device failure MICRODEBRIDER openFDA OUTCOMES SINUS 

分 类 号：R765.9[医药卫生—耳鼻咽喉科]