BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 8483521 · Received April 4, 2019

    Report

    Report Number
    3006897778-2019-00005
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    January 11, 2019
    Report Date
    April 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 "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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275365 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LTD EF-322N 322N180718 05391530810012

    Patients

    Seq Age Sex Outcome Treatment
    1