BACKGROUND Gastrointestinal(GI)bleeding accounts for over half a million admissions annually and is the most common GI diagnosis requiring hospitalization in the United States.Bipolar electrocoagulation devices are us...BACKGROUND Gastrointestinal(GI)bleeding accounts for over half a million admissions annually and is the most common GI diagnosis requiring hospitalization in the United States.Bipolar electrocoagulation devices are used for the management of gastrointestinal bleeding.There is no data on device-related adverse events for gold probe(GP)and injection gold probe(IGP).AIM To analyze this using the Food and Drug Administration(FDA’s)Manufacturer and User Facility Device Experience(MAUDE)database from 2013 to 2023.METHODS We examined post-marketing surveillance data on GP and IGP from the FDA MAUDE database to report devicerelated and patient-related adverse events between 2013-2023.The MAUDE database is a publicly available resource providing over 4 million records relating to medical device safety.Statistical analyses were performed using IBM SPSS Statistics V.27.0(IBM Corp.,Armonk,NY,United States).RESULTS Our search elicited 140 reports for GP and 202 reports for IGP,respec-tively,during the study period from January 2013 to August 2023.Malfunctions reportedly occurred in 130 cases for GP,and actual patient injury or event occurred in 10 patients.A total of 149 patients(74%)reported with Injection GP events suffered no significant consequences due to the device failure,but 53 patients(26%)were affected by an event.CONCLUSION GP and IGP are critical in managing gastrointestinal bleeding.This study of the FDA MAUDE database revealed the type,number,and trends of reported device-related adverse events.The endoscopist and support staff must be aware of these device-related events and be equipped to manage them if they occur.展开更多
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 be...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.展开更多
文摘BACKGROUND Gastrointestinal(GI)bleeding accounts for over half a million admissions annually and is the most common GI diagnosis requiring hospitalization in the United States.Bipolar electrocoagulation devices are used for the management of gastrointestinal bleeding.There is no data on device-related adverse events for gold probe(GP)and injection gold probe(IGP).AIM To analyze this using the Food and Drug Administration(FDA’s)Manufacturer and User Facility Device Experience(MAUDE)database from 2013 to 2023.METHODS We examined post-marketing surveillance data on GP and IGP from the FDA MAUDE database to report devicerelated and patient-related adverse events between 2013-2023.The MAUDE database is a publicly available resource providing over 4 million records relating to medical device safety.Statistical analyses were performed using IBM SPSS Statistics V.27.0(IBM Corp.,Armonk,NY,United States).RESULTS Our search elicited 140 reports for GP and 202 reports for IGP,respec-tively,during the study period from January 2013 to August 2023.Malfunctions reportedly occurred in 130 cases for GP,and actual patient injury or event occurred in 10 patients.A total of 149 patients(74%)reported with Injection GP events suffered no significant consequences due to the device failure,but 53 patients(26%)were affected by an event.CONCLUSION GP and IGP are critical in managing gastrointestinal bleeding.This study of the FDA MAUDE database revealed the type,number,and trends of reported device-related adverse events.The endoscopist and support staff must be aware of these device-related events and be equipped to manage them if they occur.
文摘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.
