MAUDE Adverse Event Report: COVIDIEN RADIOFREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Catalog Number	RFG2
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that during a procedure involving the rfg2 radiofrequency generator, an error code 477 was displayed, causing a roughly 10-minute delay while turning on/off (power-cycled) the generator multiple times to attempt to clear the code but was unsuccessful.The procedure was initially intended to perform an ablation on the great saphenous vein (gsv) on the right side at a proximal location.The device was not used in the patient, and no segments were treated as the generator did not function due to the generator issue, the treatment plan was altered, and the procedure was switched to stripping/phlebectomy.No patient complications have been reported as a result of this event.

• Brand Name: RADIOFREQUENCY GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21332113
• Report Number: 2183870-2025-00060
• Device Sequence Number: 15485873
• Product Code: GEI
• UDI-Device Identifier: 10884521140394
• UDI-Public: 10884521140394
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RFG2
• Device Lot Number: 090408002
• 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: 01/14/2025
• Initial Report FDA Received Date: 02/07/2025
• Date Device Manufactured: 09/23/2008
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown