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

Model Number	CP-002A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/18/2019
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, during a radio frequency ablation of barrett's esophagus extending up from esophagogastric junction (egj), they were scraping a little too aggressively in the coagulum from the esophageal wall after the first pass, then a perforation occurred in the folds of the egj.There was never any resistance on the balloon or scope at any time during the procedure.The physician believed this was a user error but would like the cleaning cap to be inspected as it seemed sharper than the usual.The patient had a pre-existing condition of obesity, gastroesophageal reflux disease (gerd), and chronic diarrhea.The patient was prepped for the procedure and was under anesthesia.They performed gastrograffin swallow twice to rule out the perforation and the perforation was closed using clips.The patient was monitored over weekend, treated with "iv abx" and was discharged.

• 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: 8960238
• Report Number: 3004904811-2019-00034
• Device Sequence Number: 2768657
• Product Code: GEI
• UDI-Device Identifier: 10884521189423
• UDI-Public: 10884521189423
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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 Expiration Date: 01/22/2022
• Device Model Number: CP-002A
• Device Catalogue Number: CP-002A
• Device Lot Number: F2508422X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/04/2019
• 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: 60 YR