MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	CA20L2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ascites (2596)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post operative ablation, severe popping occurred at 75 watts 2 minutes and 50 seconds after emprint output began.There was a risk of rupture, but there was no change in blood pressure, no bleeding symptoms, and the patient did not appear to complain of pain, so the procedure continued.The procedure was completed and the ablation was completed as expected, and a pos t-operative ct scan taken the same day showed that the ablation had been completed without any problems.At around 18:00 the same day, the doctor in charge confirmed that ascites was leaking, and a blood clot approximately 3cm in size was confirmed on the images.It was said that it was not a life-threatening complication, and the patient was currently under observation.There were no severe complications that led to death.The hospital protocol was followed: 45w for 1 minute, 60w for 1 minute, 75w for 1 minute, and 100w for 10 minutes.The tumor was hcc (hepatocellular carcinoma), the inside of the tumor was softer than usual (the antennae were more likely to move inside the tumor), and bubbles during cauterization did not appear until popping occurred (bubbles usually occur between the latter half of 45w and the first half of 75w).There was no change in the current patient condition or if the blood clot did not grow but it was reported that the hospitalization period would be extended, and there was no information that additional treatment was performed.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EMPRINT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20461921
• Report Number: 3006451981-2024-00149
• Device Sequence Number: 7718529
• Product Code: GEI
• UDI-Device Identifier: 10884521706590
• UDI-Public: 10884521706590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CA20L2
• Device Catalogue Number: CA20L2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/16/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown