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

Model Number ES-330

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 11634327
• MDR Text Key: 244423322
• Report Number: 9681384-2021-00003
• Device Sequence Number: 1
• Product Code: PIE
• UDI-Device Identifier: 05391530810043
• UDI-Public: 05391530810043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/08/2021
• Date Device Manufactured: 08/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1