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

Model Number	EF-325N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon catheter failed to inflate- failed test.New catheter brought into procedure.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN; 2800 airwest blvd, suite 160; plainfield IN 46168
• MDR Report Key: 23736198
• Report Number: 23736198
• Device Sequence Number: 21384770
• Product Code: FFX
• UDI-Device Identifier: 10884521809420
• UDI-Public: (01)10884521809420
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/31/2025
• Report Date (Section F): 10/31/2025

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-325N
• Device Lot Number: 24L0485JZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Date Report Sent to FDA: 10/31/2025