MAUDE Adverse Event Report: COVIDIEN LLC ENDOFLIP ENDO CATHETER EF-322N 16CM NASAL TIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	EF-322N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Endoflip 16cm nasal tip balloon catheter did not pass precheck.Failed equipment was not used on the patient.

• Brand Name: ENDOFLIP ENDO CATHETER EF-322N 16CM NASAL TIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LLC; 2101 faraday ave; carlsbad CA 92008
• MDR Report Key: 16270947
• Report Number: 16270947
• Device Sequence Number: 20320748
• Product Code: FFX
• UDI-Device Identifier: 10884521809413
• UDI-Public: 10884521809413
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/24/2023
• Report Date (Section F): 01/24/2023

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: 2210293JZ(20)03
• 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: 01/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• 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 Sex: Female
• Patient Weight: 119 KG
• Patient Race: White
• Date Report Sent to FDA: 01/24/2023