MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT HP; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CAGENHP
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: ca20l2, a20l2 20cm rein percutaneous antenna x1, (lot #s24eg006).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
According to the reporter, during ablation procedure, once the system was set, the physician tested the antenna, and the generator immediately displayed the red warning sign alarm with the number 4 and 3 next to it.After rebooting the generator, same alarm occurred, so the antenna was discarded and needed to be replaced by a new one.On the photo provided, a triangle error sign with a number 4 and 3 can be seen.The issue led to a cancelled procedure with the patient under anesthesia and rescheduled.The used antenna was tested with all the other parts of the system and the generator was the only failing part.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the device microwave module(mwm) was defective and cannot be replaced.The device was advised to be scrapped.It was reported that during ablation procedure, once the system was set, the physician tested the antenna, and the generator immediately displayed the red warning sign alarm with the number 4 and 3 next to it.The reported issue was confirmed.The most likely cause was was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: illuminated(red) indicated the generator has detected a system error.Microware energy activation is disabled.System errors include microwave power regulation error, internal generator temperature error, power supply stability error, and system clock error.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.

• Brand Name: EMPRINT HP
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19990296
• Report Number: 3004962788-2024-00095
• Device Sequence Number: 7075919
• Product Code: NEY
• UDI-Device Identifier: 10884521781276
• UDI-Public: 10884521781276
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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 Model Number: CAGENHP
• Device Catalogue Number: CAGENHP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown