MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CA15L2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/03/2018
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
According to the reporter, intra-operatively, approximately 30 seconds after ablation of the juxtacardiac (s2¿s lesion under the diaphragm) tumor with an output of 100 w with emprint caught a cardiac arrest for about 10 seconds from the high bradycardia.When ablation was stopped immediately, the heart beat resumed, the patient finished without sequelae.The heart and ablation prediction range was about 2 cm apart and it was judged that it was safe to burn and it was treated.The procedure was not completed and need a re-operation due to the issue.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 7819699
• Report Number: 3004962788-2018-00044
• Device Sequence Number: 1286686
• Product Code: NEY
• UDI-Device Identifier: 10884521703278
• UDI-Public: 10884521703278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CA15L2
• Device Catalogue Number: CA15L2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other