MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PLASMABLADE 4.0; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	PS200-040
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider regarding a handpiece.It was reported that during pacemaker replacement surgery the surgical site was re-prepped with an alcohol-based chlorhexidine solution following patient movement and difficulty securing iv access, which required multiple interventions.A significant amount of the antiseptic solution migrated beneath the surgical drape and saturated the underlying draping material.The handpiece was then activated before the alcohol vapors had fully dissipated, resulting in ignition and a fire beneath the drape.The fire was extinguished within approximately one minute; however, the patient sustained second- and third-degree burns.No product defect was identified.
Additional Manufacturer Narrative
(h3): no parts have been received by the manufacturer for evaluation.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.

• Brand Name: PLASMABLADE 4.0
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette,co
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette,co
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50251414
• Report Number: 1723170-2026-01150
• Device Sequence Number: 15966555
• Product Code: GEI
• UDI-Device Identifier: 00763000059842
• UDI-Public: (01)00763000059842(17)271031(10)2212008(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K073057
• 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
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PS200-040
• Device Catalogue Number: PS200-040
• Device Lot Number: 2212008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male