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

Model Number	FLEXFS-010A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Ulceration (2116); Blood Loss (2597)
Date of Event	10/27/2018
Type of Reportable Event	Serious Injury
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 patient had a radio frequency ablation of barrett's esophagus and were presented with melena and a hemoglobin (hb) of 76.Four units of blood were given and the gastroscopy was done which showed ulcerations from the procedure, but no bleeding point.There was no treatment done during the gastroscopy.The patient was prepped for the procedure and was under anesthesia, but there was no patient harm, and no repeat procedure was performed.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient had a radio frequency ablation of barrett's esophagus and was presented with melena and a hemoglobin (hb) of 76.Four units of blood was given and the gastroscopy was done which showed ulcerations from the procedure caused by the device, but no bleeding point.There was no treatment done during the gastroscopy.The patient had no history of anemia and/or gastrointestinal bleeding prior to the procedure, was prepped for the procedure and was under anesthesia, but there was no patient harm, and no repeat procedure was performed.

• 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: 8103353
• Report Number: 3004904811-2018-00042
• Device Sequence Number: 13852535
• Product Code: GEI
• UDI-Device Identifier: 10884521181304
• UDI-Public: 10884521181304
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: FLEXFS-010A
• Device Catalogue Number: FLEXFS-010A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73