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

Model Number	90-9100
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
During the case, the doctor wanted to do an ablation for barrett¿s on the patient.The machine turned on with no problem.The 90 rfa was placed onto the scope with no issues.When the doctor went to ablate the esophagus, the 90 rfa would not fire.The 90 rfa was disconnected and reconnected a few times, but it did not fire.The scope was taken out of the patient and the 90 rfa was replaced with another 90 rfa.The scope was then inserted back in the esophagus and the doctor was able to ablate with no issues with the new 90 rfa device.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17370207
• Report Number: 17370207
• Device Sequence Number: 12521628
• Product Code: GEI
• UDI-Device Identifier: 10884521189362
• UDI-Public: (01)10884521189362
• 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): 07/13/2023
• Report Date (Section F): 07/13/2023

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: 90-9100
• Device Catalogue Number: 90-1900
• Device Lot Number: B000002533
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• 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: Male
• Patient Weight: 101 KG
• Patient Race: White
• Date Report Sent to FDA: 07/13/2023