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

Model Number	RFG2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use rfg2 during procedure.It was reported that after inserting the catheter, when trying to start ablation, the device did not work.Error message was not checked at that time, but when it was checked at the time of collection, error message ¿treatment halted: non-uniform temperature¿ was displayed.A different catheter was opened and treatment was attempted, but the device could not be used due to the same error, so treatment with high frequency was given up.After that, treatment was completed by high ligation procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: the generator was power cycled and the issue still remained.Both catheters were safely removed from the patient.No vessel damage was noted.The generator has been in use since this event without issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: both catheters were inside the patient when the issue occurred.The generator was power cycled.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis:analysis: the generator was returned to japan tech service and evaluated.A service report was provided.When this product arrived in our depot, the trouble mentioned was not resumed.The running test and treatment simulation were repeated many times to investigate the problem.As there was no trouble found during testing, the ¿rf/iso thermal cable¿ was replaced as a preventive maintenance.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RADIOFREQUENCY GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9822666
• Report Number: 2183870-2020-00081
• Device Sequence Number: 3037119
• Product Code: GEI
• UDI-Device Identifier: 10884521140394
• UDI-Public: 10884521140394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2020

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: RFG2
• Device Catalogue Number: RFG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 02/24/2020; 04/08/2020; 04/15/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/25/2020; 04/14/2020; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1