MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN MAE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number MAE UNK GEN

Device Problems Fire (1245); Melted (1385); Energy Output Problem (1431); Peeled/Delaminated (1454); Failure to Power Up (1476); Smoking (1585); Device Damaged Prior to Use (2284)

Patient Problems Burn(s) (1757); Hemorrhage/Bleeding (1888)

Event Date 12/01/2011

Event Type  Injury  

Event Description

Abstract objective(s): coblation, or radiofrequency ablation, and pulsed-electron avalanche knife (peak) plasmablade are newer approaches for tonsillectomy that reduce exposure to thermal heat.This study aims to describe and compare adverse events related to these devices for tonsillectomy.Study design: retrospective cross-sectional study.Setting: the us food and drug administration's manufacture and user facility device experience (maude) database.Methods: the maude database was queried for reports involving coblation devices and the peak plasmablade from 2011 to 2021.Data were extracted from reports pertaining to tonsillectomy with and without adenoidectomy.Results: there were 331 reported adverse events for coblation and 207 for the plasmablade.For coblation, 53 (16.0 %) of these involved patients and 278 (84.0 %) were device malfunctions.Similarly for the plasmablade, 22 (10.6 %) involved patients and 185 (89.4 %) were device malfunctions.The most frequent patient-related adverse event was burn injury, which was significantly more common with the plasmablade compared to coblation (77.3 % vs.50.9 %, respectively, p = 0.042).For both the coblator and plasmablade, the most common device malfunction was intraoperative tip or wire damage (16.9 % vs.27.0 %, respectively, p = 0.010).The plasmablade tip caught fire in five reports (2.7 %) with one causing burn injury.Conclusions: while coblation devices and the plasmablade have demonstrated utility in tonsillectomy with or without adenoidectomy, t hey are associated with adverse events.Plasmablade use may require greater caution for intraoperative fires and patient burn injuries compared to coblation use.Interventions to improve physician comfort with these devices may help reduce adverse events and inform preoperative discussions with patients.1.Of the 192 mdrs reviewed in the study that met inclusion criteria there were 17 reports of burns related to the plasmablade cases.2.There were 5 intraoperative bleed instances.3.There were 50 reported damaged tips or wire during operation.4.There were 16 reported dislodgement of the device component.5.There were 7 reported instances of decreased coagulation or ablation function.6.There were 5 reported instances of the tip catching fire.7.There were 34 reported instances of tip ignition.8.There were 16 reported instances of delaminated insulating coat.9.There were 2 reported instances of compromised sterile seal.10.There were 45 instances of melted device.11.There were 2 reported instances of electrode or wand damage/arching.12.There were 3 reported instances of smoking.13.There were 5 reported instances of power issues.

Manufacturer Narrative

A1-a5) patient information was not included in the article.B3) the article did not provide the date of the procedure.The event date provided is the earliest year the reports used were submitted.B5) the article citation is included.D4) the system product number and serial number were not provided in the journal article.Udi not available for this system.G2) no 510k provided as system is unknown.H3) no evaluation was performed as the event was reported as a literature article.H4) device manufacturing date is unavailable.Note: all events and product issues reported in this article are from previously reported regulatory reports.The report numbers were not specified in the article.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN MAE GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17238616
• MDR Text Key: 318227406
• Report Number: 1226420-2023-00058
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAE UNK GEN
• Device Catalogue Number: MAE UNK GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other