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

Model Number	1190A-115A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was defective during a radiofrequency ablation of barrett's esophagus which caused mucosal laceration approximately 1 cm on the second pass from 35-36cm while the physician was describing the procedure under direct visualization.Inhalation/oral drug was used.The catheter was advanced rotating clockwise, treating 8cm proximal to distal.All items were rem oved under direct visualization by rotating the catheter clockwise, and a cleaning cup was used to scrape the coagulum.The guide wire was advanced, scope was withdrawn, and the catheter advanced rotating clockwise, then retreated 8cm area.Everything was removed under direct visualization, and the scope was advanced to evacuate gastric contents, then a 1 cm esophageal tear was identified.The patient was prepped for the procedure and was under anesthesia, was then normal and was given pain medications, no repeat procedure would be necessary.There was no radiation exposure, unanticipated blood loss, nor device fragment or component fell into the patient's cavity.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 7464765
• Report Number: 3004904811-2018-00008
• Device Sequence Number: 13480832
• Product Code: GEI
• UDI-Device Identifier: 10884521177796
• UDI-Public: 10884521177796
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K092487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 1190A-115A
• Device Catalogue Number: 1190A-115A
• Device Lot Number: FE1514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1