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

Model Number	EF-322N
Medical Device Problem Codes	Product Quality Problem (1506); Application Program Problem (2880)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they connected the catheter, they received an error "catheter not supported/catheter not connected" and the black piece that locks into the syringe was not moving to the correct position to properly fit the catheter.It took three catheters to get the problem done.The machine was turned off and on and the catheter was disconnected and reconnected, but it did not fix the problem.Technical support confirmed that the catheter connector was inserted with the green dots aligned.There was no issue with the syringe plunger and the catheter display did not have a real-time clock battery depleted/cmos error.They had an issue with archiving the data, but not the current problem, and the catheter was not difficult to remove from the patient.There was no patient and user harm, but they required an additional anesthesia.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK
• MDR Report Key: 8483521
• Report Number: 3006897778-2019-00005
• Device Sequence Number: 2015097
• Product Code: FFX
• UDI-Device Identifier: 05391530810012
• UDI-Public: 05391530810012
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: Health Professional
• Device Model Number: EF-322N
• Device Catalogue Number: EF-322N
• Device Lot Number: 322N180718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1