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

Model Number	TTS-1100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Channel rfa (radio frequency ablation) catheter would not go through the scope working channel.The type of catheter used was the barrx channel rfa endoscopic catheter.Never heard of an issue with this particular instrument before this occurrence.Doctor and the surgical technologist in the room tried multiple routes of getting down the working channel, and when it was eventually introduced into the esophagus, it was bent and not working properly.The tissue ablations were not 100% because the tissue was not getting the full contact of the paddle.The faulty catheter was taken out of the patient and a new one was used and had no difficulties.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17216046
• Report Number: 17216046
• Device Sequence Number: 20377516
• Product Code: GEI
• UDI-Device Identifier: 10884521176621
• UDI-Public: (01)10884521176621(17)250104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/21/2023
• Report Date (Section F): 06/21/2023

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: TTS-1100
• Device Lot Number: B000002397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2023
• 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
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White
• Date Report Sent to FDA: 06/21/2023