MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	FORCEFX-CS
Medical Device Problem Codes	Failure to Calibrate (2440); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
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 the temple biopsy, the patient was under partial sedation.The staff started off with a cannula, then moved to an oxygen mask.After changing to the mask, the drape covering the patient, as well as the mask, caught on fire.The patient was burnt and mask that the patient was wearing.The drape was thrown to the floor to prevent any further injury.The patient was stable after the incident and was currently at another facility recovering from injuries sustained from the burns.It was presumed that when the handpiece was used with the oxygen mask, it might have, created an oxygen rich environment, causing the fire.The biomed performed output testing using test cables and found that all out for cut, coagulation and bipolar were within specification.The cut was tested at wattage of 75, coagulation at a wattage of 30 and bipolar at a wattage of 10.No issues found.The only issue biomed found was during testing of rem (return electrode monitor) at 135 ohms--instead of getting a value of 135 plus minus 5.The biomed was getting a value of 143 ohms which is 3 points higher than specification.The patient suffered injuries from burns.

• Brand Name: FORCE FX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23292304
• Report Number: 3006451981-2025-00109
• Device Sequence Number: 20029628
• Product Code: GEI
• UDI-Device Identifier: 10884524002620
• UDI-Public: (01)10884524002620(17)160107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2016
• Device Model Number: FORCEFX-CS
• Device Catalogue Number: FORCEFX-CS
• 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: 09/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 01/25/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown