MAUDE Adverse Event Report: COVIDIEN FORCETRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	FORCETRIAD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during posterior cervical laminoplasty, when the surgeon was beginning the case, he activated the bipolar cautery and noticed smoke, a spark and then a flame come out of the bipolar forceps when the footswitch was activated.When the footswitch was let off the issue was resolved.He was holding the tip in the air and nothing on the surgical filed ignited.The surgeon was using a non-medtronic bipolar forceps.The disposable tubing used non-medtronic as well.The medtronic generator was on a setting of 35.The service coordinator removed the generator, non-medtronic bipolar tip, non-medtronic bipolar tubing and packaging from service and contacted biomed.There was no patient harm/injury.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23643101
• Report Number: 1717344-2025-01520
• Device Sequence Number: 10132681
• Product Code: GEI
• UDI-Device Identifier: 10884524001531
• UDI-Public: (01)10884524001531(11)120821
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: FORCETRIAD
• Device Catalogue Number: FORCETRIAD
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 08/21/2012
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male