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
Evaluation summary: this report is based on information provided by medtronic investigation personnel.One ef-322n was received for evaluation.The returned sample met specification as received by medtronic.The customer reported that catheter not supported in software.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.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 message "catheter not supported/catheter not con ected" and the syringe holder was not moving to the correct position for the catheter to fit, but there was no issue with the syringe plunger.It took three catheters to get this done and the machine was turned off and turned on and the catheter was disconnected and reconnected to see if that would fix the problem, but it did not.Technical support confirmed that the catheter connector was inserted with the green dots aligned.The catheter display did not have a real-time clock battery depleted/cmos error, there was an issue with archiving the data, but not the current problem, and the catheter was not difficult to remove from the patient.The catheter will be returned for investigation.There was no patient and user harm, but they required 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: 8593218
• Report Number: 3006897778-2019-00008
• Device Sequence Number: 19332446
• 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: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1