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	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter passed test prior to use, during procedure when inserted into the esophagus and inflated, balloon inflated but would not register pressure.After several attempts, another catheter was opened and set up.The newly opened catheter functioned appropriately.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LP; 6135 gunbarrel ave; boulder CO 80301
• MDR Report Key: 20852356
• Report Number: 20852356
• Device Sequence Number: 15478801
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Date Report Sent to FDA: 12/03/2024