BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 8593218 · Received May 8, 2019

    Report

    Report Number
    3006897778-2019-00008
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    January 11, 2019
    Report Date
    May 8, 2019
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    UDI-DI
    05391530810012
    PMA / PMN Number
    K160725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384307 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LTD EF-322N 322N180718 05391530810012

    Patients

    Seq Age Sex Outcome Treatment
    1