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

Model Number	EF-322N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pre-check of setup the piston syringe started to fill with air from the large black seal.The syringe was removed, and the air was removed.The device was set up using the same equipment, and the pre-check was restarted.With the attempt, the piston syringe started to leak fluid from the black seal.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 95054
• MDR Report Key: 21662404
• Report Number: 21662404
• Device Sequence Number: 18250468
• Product Code: FFX
• UDI-Device Identifier: 10884521809413
• UDI-Public: (01)10884521809413(17)261104(10)24K0299JZ(20)03
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 03/13/2025
• Report Date (Section F): 03/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: EF-322N
• Device Lot Number: 24K0299JZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 03/13/2025