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

Model Number	CA20L2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	12/04/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
After microwave ablation therapy was performed, it resulted in intraperitoneal bleeding and the patient died.According to computerized tomography (ct) examination, it was considered that the bleeding was from the route of puncture.It was also noted by the doctor that the bleeding occurred from the antenna puncture route due to hepatic artery damage at treated site.

• 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; CN 201114
• MDR Report Key: 9578608
• Report Number: 3006451981-2020-00008
• Device Sequence Number: 2197118
• Product Code: NEY
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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 Expiration Date: 09/03/2021
• Device Model Number: CA20L2
• Device Catalogue Number: CA20L2
• Device Lot Number: S9JG008X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/10/2020
• 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: Death
• Patient Age: 62 YR
• Patient Weight: 86