MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. AEX GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	40-405-1
Medical Device Problem Codes	Premature Activation (1484); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(h3,h6): no parts have been received by the manufacturer for evaluation.Codes b17, c20 <(>&<)> d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a manufacturer representative regarding a generator.It was reported that during a sacroiliac and thoracolumbar procedure, the generator, when spinning the handpiece, burned a hole through the image acquisiton system (ias) drape and singed the compression cuffs on the patient's calf.The ias was positioned on the torso portion of the patient, and everything not related to the ias was moved to the foot of the bed.The issue occurred post-operatively when site was performing the final spin on the ias and there was no impact to the patient.
Additional Manufacturer Narrative
B5: additional information was received.It was reported that the product issue identified in the handpiece not the generator.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received.It was reported that there was no malfunction associated with the generator.

• Brand Name: AEX GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; suite d; lafayette CO 30188
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; suite d; lafayette CO 30188
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24199827
• Report Number: 1723170-2026-00167
• Device Sequence Number: 13147565
• Product Code: GEI
• UDI-Device Identifier: 00763000281007
• UDI-Public: (01)00763000281007(11)200804
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40-405-1
• Device Catalogue Number: 40-405-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown