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	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, rn noted the pressure reading for the endo flip balloon was reading abnormally high at 200.The pressure reading should have been 20 or below.Rn notified the physician of the pressure reading.The decision was made to stop the procedure and obtain a new zero-pressure reading with the current catheter.The pressure reading didn't change after having the machine calculate zero pressure a second time.Endo flip catheter was removed from service.A new catheter was obtained and the procedure continued without incident.

• Brand Name: ENDOFLIP ENDO CATHETER EF-322N 16CM NASAL TIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 95054
• MDR Report Key: 16271168
• Report Number: 16271168
• Device Sequence Number: 5991398
• 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): 01/19/2023
• Report Date (Section F): 01/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: EF-322N
• Device Lot Number: 22K1008JZ(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: 64 KG
• Patient Race: White
• Date Report Sent to FDA: 01/19/2023