MAUDE Adverse Event Report: COVIDIEN LLC BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	1190A-230A
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device, without accessories, was available for evaluation.During testing, the unit was connected to an external power source and turned on without any errors.A balloon catheter was connected to the unit, and it did not consistently deliver full energy to the load.The unit also failed the pressure accuracy and leak check test, as it did not reach the expected pressure at the start.Internal inspection showed discoloration at the ends of the tubing, which were trimmed.A capacitor on the rf circuit board was broken and found loose inside the unit.The issue was resolved by replacing the rf circuit board, the pump output pneumatic tubing assembly (from the pump output to the solenoid port), and the coin cell battery.Minor adjustments were made to calibrate the rf circuit board.The unit was repaired and tested for functionality.It passed all operational, pneumatic, and functional tests.A safety test was also performed.It was reported that the generator did not deliver energy.The reported issue was confirmed.The most likely cause was traced to a component failure.The evaluation detected an unreported condition: the unit failed the pressure accuracy and leak check test.The most likely cause for the additional condition 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.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
It was reported that during the rfa (radio frequency ablation) procedure, the doctor started to apply the therapy to the patient.But for some reason the delivery of the energy from the catheter to the patient's esophagus mucosa failed.The case was canceled and was repeated two weeks later when it was completed without any issues with another generator.The patient underwent iv sedation on both initial and second procedure.
Additional Manufacturer Narrative
D10 concomitant products: 64082, 64082 barrx 360 express rfa balloon cath (lot#:b000003514), flexcc-020a, flexcc-020a barrx rfa output cable (lot#:49003218), flexfs-010a, flexfs-010a barrx rfa footswitch (lot#:012920-025x) 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: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing noted that the unit was connected to an external power source and powered on without any errors.A balloon catheter was connected, but the unit did not consistently deliver full energy on the load, producing 38%, then 100%, then 100%.The unit also failed the pressure accuracy and leak check.An internal inspection found discoloration at the ends of the tubing, which were trimmed.A damaged capacitor was found on the rf circuit board and was loose inside the unit.It was reported that the generator did not delivery energy.The reported issue was confirmed.The most likely cause was traced to component failure.The evaluation detected an unreported condition: the unit failed the pressure accuracy and leak check test.The most likely cause for the additional condition was traced to component failure.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: e1(first name and last name), e3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.It was reported that the generator did not delivery energy.The reported issue was confirmed.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: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 94085 4022
• Manufacturer (Section G): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 94085 4022
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23031144
• Report Number: 3004904811-2025-00044
• Device Sequence Number: 9216916
• Product Code: GEI
• UDI-Device Identifier: 10884521786035
• UDI-Public: (01)10884521786035(11)200806
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K160360
• 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,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 1190A-230A
• Device Catalogue Number: 1190A-230A
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/21/2026; 02/12/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/23/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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
• Patient Sex: Female