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

Model Number 90-9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to literature source of study performed, pain and dysphagia was experienced by 36 patients at 3 weeks post procedure.The pain and dysphagia that persisted after adjusting for significant variables including indication for ablation, type of procedural sedation, and whether medication was prescribed for pain after the procedure were provided in a scale.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8401928
• MDR Text Key: 138210836
• Report Number: 3004904811-2019-00007
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521189362
• UDI-Public: 10884521189362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90-9100
• Device Catalogue Number: 90-9100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other