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

Model Number	EF-322N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Endoflip measurement catheter (model #322n) failed upon set up, during calibration error code was given on monitor.Unable to use catheter.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LP; 6135 gunbarrel ave; boulder CO 80301
• MDR Report Key: 20852329
• Report Number: 20852329
• Device Sequence Number: 20843019
• Product Code: FFX
• UDI-Device Identifier: 10884521809413
• UDI-Public: (01)10884521809413(17)260628(10)24F1316JZ(20)03
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024
• Report Date (Section F): 12/03/2024

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: Other
• Device Model Number: EF-322N
• Device Lot Number: 24F1316JZ
• 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: 12/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• 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: Unknown
• Date Report Sent to FDA: 12/03/2024