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

Model Number	CA20L2
Medical Device Problem Codes	Device Alarm System (1012); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: ca20l2 20cm rein percutaneous antenna x1 (lot#: s24ag005); cagenhp, hp ablation gen cagenhp (serial (b)(6); ca190rc1 ablation reusable cable x1 (serial (b)(6); capump1 ablation pump x1 (serial (b)(6) 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.
Event or Problem Description
According to the reporter, during the procedure, the ablation was set for 150watt and 10 min, the generator activated a temperature alarm system error stopping the treatment at 3 min.The cooling water system had been checked and found no default of installations.The water had been changed.A second antenna was opened and tested, and the alarm rang directly.At that point, it was not possible to identify if the cause was the reusable cable, the generator or the pump.All three were tested separately to determine which one should receive maintenance.Two different antennas had been used without effect during these procedures.The biomedical engineer tested a second antenna, a second reusable cable, and a second water cooling unit, all leading to the same temperature error.However, in a second time, sales rep did a second test session, where tried to assess if it was their generator that was at the origin of the problem, by comparing with the demonstration of the unit.Appeared than the same alarm occurred with the generator.Two antennas used during the issue shared the same serial number.Tried with a different serial number antenna, no temperature alarm occurred on the generator, and no alarm occurred as well on the center¿s generator.The procedure was cancelled, and patient was under anesthesia.

• 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: 19735548
• Report Number: 3006451981-2024-00095
• Device Sequence Number: 15233210
• Product Code: GEI
• UDI-Device Identifier: 10884521806559
• UDI-Public: 10884521806559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: CA20L2
• Device Catalogue Number: CA20L2
• Device Lot Number: S24AG005
• 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: 06/20/2024
• Initial Report FDA Received Date: 07/12/2024
• Date Device Manufactured: 01/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown