MAUDE Adverse Event Report: CROSPON LTD ENDOFLIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	EF-322N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the catheter was entered into the trachea instead of the esophagus.There was a minor bleeding.The catheter was never filled with fluid while inside the patient.The physician realized the location and removed the catheter without hesi tation/resistance.The staff worked to stabilize the patient and ordered chest x-rays.The x-rays came back ok and the patient was cleared to go home.They did not move forward with the case and it was canceled.The patient had a suspected swallowing disorder.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK; EI H91P2DK
• Manufacturer (Section G): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK; EI H91P2DK
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 14227316
• Report Number: 3006897778-2022-00001
• Device Sequence Number: 11827482
• Product Code: FFX
• UDI-Device Identifier: 05391530810012
• UDI-Public: 05391530810012
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K160725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EF-322N
• Device Catalogue Number: EF-322N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown