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

Model Number	EF-325N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Probe did not calibrate correctly.Found prior to patient use.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LP; 2101 faraday avenue; carlsbad CA 92008
• MDR Report Key: 17001775
• Report Number: 17001775
• Device Sequence Number: 7168189
• Product Code: FFX
• UDI-Device Identifier: 10884521809420
• UDI-Public: 10884521809420
• 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): 05/18/2023
• Report Date (Section F): 05/18/2023

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-325N
• Device Catalogue Number: EF-325N
• Device Lot Number: 22F1179JZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/18/2023