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

Model Number 1190A-230A

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Sore Throat (2396)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a week post radio frequency ablation procedure, the patient was admitted to the hospital due to throat pain and dysphagia.The patient was given pain reliever and placed on liquid diet.There were no error codes flagged during the procedure.

Event Description

According to the reporter, a week post inlet patch radio frequency ablation procedure, the patient was admitted to the hospital due to throat pain and dysphagia.The patient was given pain reviler both orally and intravenously and placed on liquid diet to regulate the pain and dysphagia.The customer noted that there were no error codes flagged during the procedure.The physician was not attributing the hospitalization to the device and was confident that it was due to the procedure.The patient's throat pain and dysphagia were resolved, and the patient was discharged.

Manufacturer Narrative

Additional information: if information is provided in the future, a supplemental report will be issued.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8422958
• MDR Text Key: 138892226
• Report Number: 3004904811-2019-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

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
• Device Operator: Health Professional
• Device Model Number: 1190A-230A
• Device Catalogue Number: 1190A-230A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention