MAUDE Adverse Event Report: COVIDIEN VALLEYLAB FX8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	VLFX8GEN
Medical Device Problem Codes	Failure to Calibrate (2440); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: e2516h, e2516h disp handswitching pencil x50 (lot#:unknown), unknown pencil, unknown pencil (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
It was reported that during the near end of the procedure during skin suturing, the operator used 25w power for coagulation.Large electric sparks appeared on the patient's skin when the pencil was activated, and the pencil leaked electricity.The rem (return electrode monitoring) indicator light on the unit remained green and the unit did not issue any alarms.The patient had a superficial second-degree electrical burn in the lower uterine segment of the lower abdomen and the routine traverse incision of the c-section.The patient was under anesthesia at the time of the electric shock injury with no obvious discomfort.The hospital stay was prolonged for one and a half days but there were scars at the incision site.At present, the patient has been discharged from the hospital and the specific size could not be determined.The specific treatment measures could not be understood.

• Brand Name: VALLEYLAB FX8
• 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: 23473998
• Report Number: 1717344-2025-01433
• Device Sequence Number: 10499852
• Product Code: GEI
• UDI-Device Identifier: 10884521707306
• UDI-Public: (01)10884521707306(11)230503(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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 Model Number: VLFX8GEN
• Device Catalogue Number: VLFX8GEN
• 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: 10/14/2025
• Initial Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 05/03/2023
• 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.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 28 YR
• Patient Sex: Female