MAUDE Adverse Event Report: COVIDIEN LP ENDOFLIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	EF-322N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device will typically inflate a balloon catheter and give feedback on the patients motility.This particular balloon catheter failed to inflate with multiple attempts.This equipment did not functioning properly and increased the time of the procedure and the amount of times that the esophagus was passed through with devices.Increasing the risk of the procedure.
Event or Problem Description
The device will typically inflate a balloon catheter and give feedback on the patients motility.This particular balloon catheter failed to inflate with multiple attempts.This equipment did not functioning properly and increased the time of the procedure and the number of times that the esophagus was passed through with devices.Increasing the risk of the procedure.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LP; 2800 airwest blvd, suite 160; plainfield IN 46168
• MDR Report Key: 22166480
• Report Number: 22166480
• Device Sequence Number: 9383002
• Product Code: FFX
• UDI-Device Identifier: 10884521809413
• UDI-Public: (01)10884521809413(17)270319(10)25C1039JZ(20)04
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025
• Report Date (Section F): 06/03/2025

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 Model Number: EF-322N
• Device Lot Number: 25C1039JZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 24 MO
• Patient Sex: Male
• Date Report Sent to FDA: 06/03/2025