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

Model Number	64082
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) of Esophagus (2398)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
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
It was reported that after the rfa (radio frequency ablation) procedure for barrett¿s esophagus, during extraction in clockwise rotary motion, the device still unwound.There was temporary injury of bleeding as there was slight abrasion in the esophagus.
Event or Problem Description
It was reported that after the rfa (radio frequency ablation) procedure for barrett¿s esophagus, during extraction in clockwise rotary motion, the device still unwound.There was temporary injury of bleeding as there was slight abrasion in the esophagus to which adrenaline injection was given as an intervention.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.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: 22543013
• Report Number: 3004904811-2025-00038
• Device Sequence Number: 7029221
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: (01)10884521211599(17)270129(10)B000002999(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 64082
• Device Catalogue Number: 64082
• Device Lot Number: B000002999
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/20/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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
• Patient Sex: Unknown