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

Model Number	CAGEN1
Medical Device Problem Codes	Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a procedure at 100w for 7 minutes protocol, with every process checked, worked until the 6th minute then red sign general warning, made the physician unable to finish the procedure even after restarting the generator after 10 minutes switched off.No abnormal heat, only one general alarm sign, steady.The facility was waiting for the post op ct-scan coming in 6 weeks to assess if procedure destruction covered the cancer lesion enough, otherwise peripheral relapse would be due the antenna malfunctioning.Procedure was aborted.When the procedure was performed after it was postponed, the facility used the demo generator with their cable and pump, and everything worked fine.On the other hand, the working antenna and test the generator with sales rep cable and pump, and the generator was still showing a red alarm sign.
Additional Manufacturer Narrative
D10 concomitant products: ca15l2, ca15l2 15cm rein percutaneous antenna x1, (lot #s23kg011); ca190rc1, ca190rc1 ablation reusable cable x1, (sn: (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.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the device failed power test and microwave operating frequency bandwidth test.The fault was identified with left-173 m icrowave source module (msm).The left-173 microwave source module was replaced to address the condition.It was reported that there was adverse event without identified device or use problem.And there was alarm activation.The reported issues were confirmed.The most likely cause was traced to component failure.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: 19111568
• Report Number: 3004962788-2024-00025
• Device Sequence Number: 15258018
• Product Code: GEI
• UDI-Device Identifier: 10884521190771
• UDI-Public: 10884521190771
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 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: Not provided
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• 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: Required Intervention; Other
• Patient Sex: Unknown