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

Model Number	CA30L2
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: a1, b5, b7, g3, rfr code (head excessive) was removed.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient with cirrhosis, hepatocellular carcinoma was treated with microwave ablation for a liver tumor.An unintended tissue damage was observed.The procedure was completed successfully with the original product, and there was no delay in overall procedure time or need for additional treatment or surgery.No error or messages occurred during procedure.Setting were 150 watts for 2:30 minutes for a 3.5 x 4.1 cm ablation.However, on post operative day 1 ct (computed tomography) scan, the ablation cavity was up to 5.9 centimeter in diameter, well above the predicted ablation diameter of 4.1 centimeter.Ct imaging argue for some hepatic steatosis, in addition to cirrhosis.
Additional Manufacturer Narrative
Additional information: g3 correction: h6 (heat excessive code was removed.Customer feedback code was added.) 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient with cirrhosis, hepatocellular carcinoma was treated with microwave ablation for a liver tumor.An unintended tissue damage was observed.The procedure was completed successfully with the original product, and there was no delay in overall procedure time or need for additional treatment or surgery.No error or messages occurred during procedure.However, on post operative day one ct (computed tomography) scan, the ablation cavity was up to 5.9 centimeter in diameter, well above the predicted ablation diameter of 4.1 centimeter.Ct imaging argue for some hepatic steatosis, in addition to cirrhosis.

• Brand Name: EMPRINT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24233752
• Report Number: 3006451981-2026-00012
• Device Sequence Number: 9183816
• Product Code: GEI
• UDI-Device Identifier: 10884521806566
• UDI-Public: (01)10884521806566(17)270617(10)S25FG011(20)05
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: CA30L2
• Device Catalogue Number: CA30L2
• Device Lot Number: S25FG011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/26/2026; 02/03/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/04/2026; 02/10/2026
• Date Device Manufactured: 06/17/2025
• 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: Female
• Patient Weight: 85 KG