MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CA20L1
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during ablation procedure, after locating the lesion under color doppler ultrasound, the needle tip penetrated the lesion, pre-heating at 45w for 1minutes, 65w for 2minutes, and then 75w for 5minutes (setting), 4minutes after ablation, the machine malfunctioned, and the water circulation was normal.They changed the antenna but still did not work.The ablation was incomplete and they change the procedure tace (transarterial chemoembolization) interventional therapy.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13192836
• Report Number: 3006451981-2022-00003
• Device Sequence Number: 11863186
• Product Code: NEY
• UDI-Device Identifier: 10884521725959
• UDI-Public: 10884521725959
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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: 06/19/2023
• Device Model Number: CA20L1
• Device Catalogue Number: CA20L1
• Device Lot Number: S8FG013CX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/07/2022
• Date Device Manufactured: 06/20/2018
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 65 KG