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

Model Number	ES-330
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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 screen of the system froze and could not tell if the catheter continued to inflate.There was no patient and user harm.

• Brand Name: ESOFLIP
• Common Device Name: ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• MDR Report Key: 11634327
• Report Number: 9681384-2021-00003
• Device Sequence Number: 3657485
• Product Code: PIE
• UDI-Device Identifier: 05391530810043
• UDI-Public: 05391530810043
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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 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: 03/19/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1