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

Model Number	PS210-030S-LIGHT
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider regarding a handpiece.It was reported that the handpiece would start without anyone touching the power button.A new handpiece was used to continue with surgery.There was no delay and no impact on patient outcome.
Additional Manufacturer Narrative
A.Conflicting information was provided on patient involvement.Follow-up has been conducted and a supplemental report will be submitted should additional information become available.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 X 3.0S LIGHT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19043122
• Report Number: 2182208-2024-01473
• Device Sequence Number: 20650631
• Product Code: GEI
• UDI-Device Identifier: 00763000279165
• UDI-Public: 00763000279165
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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 Expiration Date: 07/31/2026
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: 2208125
• 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: 03/20/2024
• Initial Report FDA Received Date: 04/04/2024
• Date Device Manufactured: 08/28/2023
• 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
• Patient Sex: Unknown