MAUDE Adverse Event Report: MEDTRONIC, INC. VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	SEP6015
Medical Device Problem Codes	Fire (1245); Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during open abdominoperineal resection, the pencil was removed from the tissue after activation, it was noticed the tip of the electrode had a flame on it while no longer activating on patient tissue.The match-size flame on the cautery pencil electrode left a white colored area on the electrode.It was unclear if the issue was due to the pencil or the ft10 or due to tissue build up on the electrode.The facility¿s biomed inspection of the device and generator revealed the ft10 logs displayed ¿stuck button.¿ no operating room fire noted.There was no patient injury.
Event or Problem Description
According to the reporter, during open abdominoperineal resection, the pencil was removed from the tissue after activation, it was noticed the tip of the electrode had a flame on it while no longer activating on patient tissue.The match-size flame on the cautery pencil electrode left a white colored area on the electrode.It was unclear if the issue was due to the pencil or the ft10 or due to tissue build up on the electrode.The facility¿s biomed inspection of the device and generator revealed the ft10 logs displayed ¿stuck button", it also had an e322 error code and also a monopolar 1 port damage.No operating room fire noted.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g1, g3 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
D10 concomitant product: vlft10gen ft series energy platformx1 t7l21180dx.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.
Event or Problem Description
According to the reporter, during open abdominoperineal resection, the pencil was removed from the tissue after activation, it was noticed the tip of the electrode had a flame on it while no longer activating on patient tissue.Smoke was visible.Surgeon and another staff member reported seeing an orange flame on the cautery pen tip.The match-size flame on the cautery pencil electrode left a white colored area on the electrode.It was unclear if the issue was due to the pencil or the ft10 or due to tissue build up on the electrode.Cautery device was taken out of use.The facility¿s biomed inspection of the device and generator revealed the ft10 logs displayed ¿stuck button", it also had an e322 error code and also a monopolar 1 port damage.No operating room fire noted.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the sample returned with complaint number on the bag, and about 1/5 of the coating is missing and damaged on the electrode blade, and eschar remained on the tip of the electrode.Functionally, x-ray examination confirmed the processing assembly of the returned sample is correct.It was reported that the device caught fire.The reported issue could not be confirmed.The most likely cause was use and energy accumulation.It was also reported that the activation button on the device stayed in the on position by itself.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: tissue buildup (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen-enriched environments.Eschar plus high oxygen may create embers.Keep the electrode clean and free of all debris.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: VALLEYLAB
• 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 st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14399698
• Report Number: 2182208-2022-01553
• Device Sequence Number: 5451912
• Product Code: GEI
• UDI-Device Identifier: 10884521750937
• UDI-Public: 10884521750937
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K182772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/18/2023

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: SEP6015
• Device Catalogue Number: SEP6015
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 07/27/2022; 01/13/2023
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/03/2022; 08/12/2022; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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