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

Model Number EF-322N

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2022

Event Type  malfunction  

Event Description

It was reported that while setting up the endoflip catheter 16cm nasal tip for use during the procedure, the medtronic endoflip machine noted the catheter to be defective during the initial diagnostic analysis.The catheter was removed from the machine and a new catheter was placed.

• Brand Name: ENDOFLIP
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 95054
• MDR Report Key: 16014111
• MDR Text Key: 305802005
• Report Number: 16014111
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2022
• Date Report to Manufacturer: 12/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 161 KG
• Patient Race: White