MAUDE Adverse Event Report: MEDTRONIC, INC. PLASMABLADE X PS210-030S-LIGHT 3.0SL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	PS210-030S-LIGHT
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(h3, h6): no parts have been received by the manufacturer for evaluation.Codes b17, c20 & d15 are applicable.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
2026-mar-11 00875614 sap ecc service and repair 000304554782 (hcp): information was received from a healthcare provider regarding a generator and handpiece.It was reported that, during surgery, a handpiece produced sparks, and sparks were also observed coming out of the generator.The issue occurred intra-operatively, patient was involved but no reported impact.

• Brand Name: PLASMABLADE X PS210-030S-LIGHT 3.0SL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24796244
• Report Number: 2182208-2026-16881
• Device Sequence Number: 9944515
• Product Code: GEI
• UDI-Device Identifier: 00763000279165
• UDI-Public: (01)00763000279165(17)280630(10)2407109(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: Health Professional
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: 2407109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown