MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) ESOFLIP; ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE

Model Number	ES-330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation of Esophagus (2399)
Date of Event	05/04/2021
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 catheter passed pre-use check.When they took the catheter out and when back in with the scope, they saw a perforation.The patient had a torturous esophagus.They put a stent in to help with drainage.The patient has an existing condition of achalasia.The patient was doing fine.

• Brand Name: ESOFLIP
• Common Device Name: ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• MDR Report Key: 11912110
• Report Number: 9681384-2021-00012
• Device Sequence Number: 1390165
• Product Code: PIE
• UDI-Device Identifier: 05391530810043
• UDI-Public: 05391530810043
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 08/21/2022
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Device Lot Number: 20H0545JZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/01/2021
• 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: 79 YR