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

Model Number	FORCEFX-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: e2100 reusable handswitching pencil - e2100, lot# 232610052r 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 scalp lipoma exeresis surgery, the electric scalpel pen had a technical defect (sparks), causing slight burn on scalp and some hair strands.The non-medtronic brand return electrode plate was located at the back of the left thigh.
Additional Manufacturer Narrative
Additional information: b5, d4 (serial number), 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 of the photo noted an adverse event occurring on the tissue of the patient.It could not be determined what caused the adverse event based on the photo sample provided.It was reported that the electric scalpel pen had a technical defect (sparks), causing second degree burn on cervical, scalp and some hair strands.A potentially related device issue was 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.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 scalp lipoma exeresis surgery, the electric scalpel pen had a technical defect (sparks), causing second degree burn on cervical, scalp and some hair strands.The burned body surface area was approximately 0.5% to 1%, affecting a right lateral strip of the scalp and a small area on the right ear.Cleaned the burned area with 0.9% saline solution and applied an occlusive dressing with aquacel ag (hydrofiber with silver) and crepe bandage.Subsequently, used 1% silver sulfadiazine cream, changing the dressing daily.The non-medtronic brand return electrode plate was located at the back of the left thigh.Photo observation showed first degree burn.The patient was okay, without injuries.

• Brand Name: FORCE FX-CS
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21858244
• Report Number: 3006451981-2025-00048
• Device Sequence Number: 4719467
• Product Code: GEI
• UDI-Device Identifier: 10884524002620
• UDI-Public: 10884524002620
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 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: 04/02/2025
• Supplement Date Received by Manufacturer: 07/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Female