MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR-REFURB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	40-405-1R
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis summary: upon testing the generator, no/insufficient bipolar energy was issue not confirmed.It was found that the unit passed all initial tests/bipolar power was in a passing ranges.Not able to duplicate issue in lab.H6: codes b01, c19, d14 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 procedure, there was no or insufficient bipolar energy identified with the generator.There was no reported impact on patient.2025-oct-29 e1 (rep): additional information was received.It was reported that the surgeon would activate the device (by pressing the cut or coag button) but it would not deactivate when her finger came off the button.The device was still activated even though she was not pressing the button at all.It would remain until she grounded it on the patient or other object.The problem occurred intra-operatively during breast surgery (mastectomy) and there was no impact to patient.Issue caused minor delays of less than an hour.

• Brand Name: AEX GENERATOR-REFURB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23603901
• Report Number: 1226420-2025-00050
• Device Sequence Number: 21311666
• Product Code: GEI
• UDI-Device Identifier: 00763000280321
• UDI-Public: (01)00763000280321(11)170531
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 40-405-1R
• Device Catalogue Number: 40-405-1R
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2017
• 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