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

Model Number	FLEXFS-010A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
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, after 20 applications with the catheter, it stopped to deliver energy and they got an error message e92 "clean electrode press reset".They tried to clean the electrode and did a reset with the generator a few times but it did not solve the problem.The procedure was gastric antral vascular ectasia and the patient came with chronic bleeding from the stomach.The procedure was aborted and a repeat procedure will be needed scheduled on another day.There was no patient and user harm.

• 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: 8799413
• Report Number: 3004904811-2019-00031
• Device Sequence Number: 11383885
• Product Code: GEI
• UDI-Device Identifier: 10884521181304
• UDI-Public: 10884521181304
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: FLEXFS-010A
• Device Catalogue Number: FLEXFS-010A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 90