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

Model Number	EF-325N
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event description it was reported that the catheter failed the pre-use check and was attempted twice.Another catheter was used successfully.There was no patient or user harm.The reported condition was not confirmed.Functional testing of the return device confirmed a unreported issue.The root cause of the observed condition was determined to be a result of a manufacturing activity.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection of the returned syringe noted that there was a black foreign object suspended in the saline.Functional testing noted that the balloon was manually inflated and there were no observed leaks.The device was found to functional normally and within specifications.The reported issue could not be confirmed.The evaluation detected an unreported condition: saline contamination.The most likely cause was determined to be manufacturing related.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24860005
• Report Number: 9681384-2026-00431
• Device Sequence Number: 9271650
• Product Code: FFX
• UDI-Device Identifier: 10884521809420
• UDI-Public: (01)10884521809420(17)260402(10)24D0141JZ(20)03
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 04/02/2026
• Device Model Number: EF-325N
• Device Catalogue Number: EF-325N
• Device Lot Number: 24D0141JZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown