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

Model Number	ACT2030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Discoloration (2074); No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after radiofrequency ablation, the skin on the right thigh of the patient was red, one 1centimeter(cm)x4cm, and two 1 cm x 1 cm blisters appeared, and had mild skin burn.
Additional Manufacturer Narrative
Evaluation summary: two devices were received for evaluation.The gel was intact with no voids on all of the devices.The gel was in the correct location.No bare foil was noted.The investigation found the gel has maintained its position on the foil.The pad has electrical continuity as measured to the ie 60601-2-2:2009 subsection 201.15.101.2 standard.The investigation could not determine the root cause of the customer's report.The instructions for use(ifu) states, select a muscular, well vascularized, convex area in close proximity to the surgical site for grounding pad application.Avoid scar tissue, bony prominences, excessive adipose tissue, and areas where fluid might pool.Position the pads an equal distance from the treatment area.Ensure that the grounding pads do not touch each other.Apply the pads by laying one edge on the skin and smoothly pressing across the pad until it is fully in contact with the skin.Apply finger pressure on the adhesive borders and massage the entire pad area to ensure proper contact.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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9106898
• Report Number: 1717344-2019-01203
• Device Sequence Number: 13991253
• Product Code: GEI
• UDI-Device Identifier: 10884524001227
• UDI-Public: 10884524001227
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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 Expiration Date: 03/04/2021
• Device Model Number: ACT2030
• Device Catalogue Number: ACT2030
• Device Lot Number: 80890062X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1