MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PlasmaBlade¿ X; Electrosurgical, cutting coagulation accessories

Model Number	PS210-030S
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The plasma blade caught fire.The equipment was not touching the patient when this happened.No harm to patient in anyway.Fluids were on the field and the fire was immediately put out.Lot#211006 exp:10-31-2028 reference# ps210-030s.

• Brand Name: PlasmaBlade¿ X
• Common Device Name: Electrosurgical, cutting coagulation accessories
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 50713860
• Report Number: 50713860
• Device Sequence Number: 16098667
• Product Code: GEI
• UDI-Device Identifier: 00763000059811
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/23/2026
• Report Date (Section F): 06/23/2026

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: Other
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 2411006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/23/2026