MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030S
Medical Device Problem Codes	Electromagnetic Interference (1194); Noise, Audible (3273)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a generator.It was reported that during a surgery involving the replacement of a deep brain stimulation device, a strange sound, described as similar to the noise of a honeybee, was emitted from the handpiece.The patient, who was undergoing the procedure under local anesthesia, reported feeling currents in the area around the existing device.The settings on the generator were cut 5 and coag 6.The issue was observed intr a-operatively, and the surgeon decided to stop using the handpiece for the remainder of the surgery.The procedure was completed without further use of the device.The site also mentioned that they believe the pump cover fit too loosely and were concerned that surface disinfectant could flow into the generator.Additional information was received.It was reported that there was a delay of around 10 min due to the sound check of the generator and handpiece.
Additional Manufacturer Narrative
H3: upon receiving the devices, they looked used with no damage.The device was decontaminated then tested.Once the device was plugged into the generator, a manufacturer representative (rep) tested the handpiece cut at 5 and coag at 6 on the chicken piece per complaint.The handpiece did work; however, it was noted there was a buzzing sound when testing the coag.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 3.0S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20878792
• Report Number: 1226420-2024-00051
• Device Sequence Number: 18353809
• Product Code: GEI
• UDI-Device Identifier: 00763000059811
• UDI-Public: (01)00763000059811(17)261130(10)2211077
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K093695
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 2211077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown