BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC ENDOCUFF

    MDR report key: 5173698 · Received October 24, 2015

    Report

    Report Number
    1651395-2015-00009
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    September 23, 2015
    Report Date
    October 23, 2015
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CASE STATES THAT AN ARC ENDOCUFF AEC120 CAME OFF MID-PROCEDURE. MEDIVATORS SALES REPRESENTATIVE STATED THAT THE ENDOCUFF DETACHED FROM THE DISTAL END OF THE SCOPE WHILE THE PHYSICIAN WAS PERFORMING COLONOSCOPY PROCEDURES. THE DEVICE HAD TO BE REMOVED FROM THE COLON USING A ROTH RETRIEVAL NET WHICH DELAYED THE PROCEDURE. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENTS. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED WITHIN MEDIVATORS COMPLAINT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705872 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD AEC120 045246

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention