MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1450-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994); Electric Shock (2554); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial (b)(6); e0560, accessory rem patient return elect (lot#unknown).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
According to the reporter, during procedure, the hospital's spine surgeon reported an incident in which a non-medtronic smoke evacuation monopolar handpiece, which had been placed on the patient's chest on the back and had apparently been accidentally activated under the surgeon's arm during the final stages of surgery and caused a burn to the surgeon's hand.The surgeon had felt an electric shock, pain, and heard a buzzing sound.The surgeon had pulled his hand away from the incident, causing the handpiece to fly to the floor.Two 2-3mm burn spots were found on the skin of the surgeon's arm.Now 4 days after the incident, the surgeon is doing well and the burn has not required any significant treatment.The monopolar instrument had been used throughout the surgery and had functioned without any problems.The patient did not suffer any effects from the incident.The handpiece was connected to a generator at the time of the event.
Event or Problem Description
According to the reporter, during procedure, the hospital's spine surgeon reported an incident in which a non-medtronic smoke evacuation monopolar handpiece, which had been placed on the patient's chest on the back and the surgeon leaned on the monopolar handpiece and it accidentally activated, causing a burn to the surgeon's hand during the final stages of surgery and caused a first degree burn to the surgeon's hand.The surgeon had felt an electric shock, pain, and heard a buzzing sound.The surgeon had pulled his hand away from the incident, causing the handpiece to fly to the floor.Two 2-3 mm burn spots were found on the skin of the surgeon's arm.There was no treatment done to the burn.Now, four days after the incident, the surgeon is doing well and the burn has not required any significant treatment.The monopolar instrument had been used throughout the surgery and had functioned without any problems.The patient did not suffer any effects from the incident.The handpiece was connected to a generator at the time of the event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the surgeon's arm was shown.The product was not shown in the picture.It was reported that there was a device related burn.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21124031
• Report Number: 1717344-2025-00057
• Device Sequence Number: 8733076
• Product Code: GEI
• UDI-Device Identifier: 10884521713123
• UDI-Public: 10884521713123
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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: E1450-4
• Device Catalogue Number: E1450-4
• Device Lot Number: 242670303R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 03/04/2025; 03/25/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/11/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown