MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number RFA2030

Device Problems Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Further review of the event found that the involved device is a product that is not sold within the united states.No further reports will be sent for this event.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 Description

According to the reporter, a bone tumor enlarged up to 6cm was found from the inguinal meridian of the left foot.In response, rfa was performed.Cauterization was performed in two sections: first site-30 watt start cauterization was performed at 10 watt/min (upper limit 90w).At about 14 minutes of cauterization time, an alarm of return electrode exceeding the temperature has occurred.Cauterization was performed with amperage 1.4a, so the return electrode alarm sounded.Because the cauterization of the tumor site was not good, cauterization was started again after 1 minute has passed.The first cauterization was completed after 30 minutes.Cauterization of the second site was performed for 20 minutes, and cauterization was completed for a total of 50 minutes.After the procedure, the return electrode was removed, and the patient was transferred to the ward.A 1mm small blister approximately 2cm wide was found on the right foot.It was suspected that it was a return electrode burn.

Event Description

According to the reporter, a bone tumor enlarged up to 6cm was found from the inguinal meridian of the left foot.In response, rfa was performed.Cauterization was performed in two sections: first site-30 watt start cauterization was performed at 10 watt/min (upper limit 90w).At about 14 minutes of cauterization time, an alarm of return electrode exceeding the temperature has occurred.Cauterization was performed with amperage 1.4a, so the return electrode alarm sounded.Because the cauterization of the tumor site was not good, cauterization was started again after 1 minute has passed.The first cauterization was completed after 30 minutes.Cauterization of the second site was performed for 20 minutes, and cauterization was completed for a total of 50 minutes.After the procedure, the return electrode was removed, and the patient was transferred to the ward.A 1mm small blister approximately 2cm wide was found on the right foot.It was suspected that it was a return electrode burn.Prolonged ablation might have been the caused.But later informed there was not burn.Surgeon used the devices throughout the procedure.There was no patient injury.

Manufacturer Narrative

New information has been received, and reassessment of the complaint found that it is no longer a reportable event.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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: COOL-TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18479749
• MDR Text Key: 332606319
• Report Number: 1717344-2024-00073
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFA2030
• Device Catalogue Number: RFA2030
• Device Lot Number: 30930140X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1