BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC ENDOCUFF

    MDR report key: 4935796 · Received July 23, 2015

    Report

    Report Number
    1651395-2015-00008
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 23, 2015
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THREE ENDOCUFF FINGERS DETACHED FROM THE ENDOCUFF BODY INSIDE THE PATIENT DURING AN ENDOSCOPIC PROCEDURE. THE FINGERS WERE REMOVED FROM THE PATIENT USING A ROTH RETRIEVAL NET WITH NO HARM TO THE PATIENT. MEDIVATORS IS STILL IN CLOSE CONTACT WITH THE FACILITY AND DEVICE MANUFACTURER. DEVICE INVESTIGATION IS STILL UNDERWAY. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479535 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD AEC130 045430

    Patients

    Seq Age Sex Outcome Treatment
    1