MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CAGEN1
Medical Device Problem Codes	Device Alarm System (1012); Overheating of Device (1437); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
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
According to the reporter, during ablation after first ct scan to verify the kidney lesion when the surgeon mark the procedure area and turning the device on, the overheat alarm start sound and after that reset the system on reset button and re-tried to turn back on the system and the overheat alarm return back.Patient was already under anesthesia and the surgeon cancelled the kidney ablation and rescheduled to (b)(6).
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection revealed that two mounting screws and two base plate feet were missing.A damaged connector pin was identified as the likely cause of the reported fault.The battery on the power regulator board was replaced.Service instructions were followed to complete the repair process.The baseplate, enclosure lid, generator feet, and spacers were replaced.Additional components including the front panel connector, microwave cable, front panel assembly, overlay, dial spacers, and knobs were also replaced.The msm module and power supply unit were replaced.Finally, the generator was calibrated according to the specified procedure.It was reported that during the ablation procedure, following the initial ct scan to verify the kidney lesion, the surgeon marked the target area and powered on the device.At that point, the overheat alarm began sounding.The system was then reset using the reset button, but when the device was powered on again, the overheat alarm reappeared.The reported issues were confirmed.The most likely cause was traced to a component failure.The evaluation detected unreported conditions: ra11.04, ra12.06, ra34.08, ra01.02 and ra47.02.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & 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: 19735821
• Report Number: 3004962788-2024-00084
• Device Sequence Number: 15547523
• Product Code: GEI
• UDI-Device Identifier: 10884521190771
• UDI-Public: 10884521190771
• Combination Product (Y/N): N
• PMA/510(K) Number: K133821
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: CAGEN1
• Device Catalogue Number: CAGEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male