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

Model Number	TTS-1100
Medical Device Problem Codes	Smoking (1585); Sparking (2595); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during rfa (radiofrequency ablation) procedure for squamous intraepithelial neoplasia, the catheter electrode sparked and smoke was observed.After the electrode was withdrawn, damage was observed on the electrode surface.There was no reported patient outcome.
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.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, 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.
Event or Problem Description
It was reported that during radio frequency ablation (rfa) procedure for squamous intraepithelial neoplasia, the catheter electrode sparked under endoscopy, at the ablation electrode site, and smoke was observed.The lead was removed and surgery was stopped.After the electrode was withdrawn, damage was observed on the electrode surface.There was no patient or user harm.
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.Visual inspection noted damage to the catheter electrode.Functional testing noted that the catheter eeprom was read and check electrode errors were observed.The catheter was connected to a halo flex generator and recognized as used.The gold key converter was connected to the catheter and five ablations were performed without difficulty.It was reported that the device fired and was smoking.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the endoscopic catheter had damaged electrodes.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.
Event or Problem Description
It was reported that during rfa (radiofrequency ablation) procedure for squamous intraepithelial neoplasia, the catheter electrode sparked under endoscopy, at the ablation electrode site, and smoke was observed.It was also noted that an alarm was triggered.The lead was removed and surgery was stopped on that day and rescheduled for an esd (endoscopic submucosal dissection) procedure.After the electrode was withdrawn, damage was observed on the electrode surface.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, g3, h1, imf code new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted damage to the catheter electrode.Functional testing noted that the catheter eeprom was read and check electrode errors were observed.The catheter was connected to a halo flex generator and recognized as used.The gold key converter was connected to the catheter and five ablations were performed without difficulty.It was reported that the device was on fire and smoking.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the endoscopic catheter had damaged electrodes.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: 23616839
• Report Number: 3004904811-2025-00050
• Device Sequence Number: 9032152
• Product Code: GEI
• UDI-Device Identifier: 10884521581753
• UDI-Public: (01)10884521581753(17)270317(10)B000003509(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/13/2026

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: TTS-1100
• Device Catalogue Number: TTS-1100
• Device Lot Number: B000003509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 12/12/2025; 12/11/2025; 02/12/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/04/2025; 12/17/2025; 01/06/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female