BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 6310305 · Received February 8, 2017

    Report

    Report Number
    1528319-2017-00008
    Event Type
    Injury
    Date Received
    February 8, 2017
    Report Date
    February 8, 2017
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ENDORINGS DEVICE IS INTENDED TO BE ATTACHED TO THE DISTAL END OF THE ENDOSCOPE TO FACILITATE ENDOSCOPIC THERAPY, TO BE USED FOR THE FOLLOWING: KEEPING THE SUITABLE DEPTH OF ENDOSCOPE FIELD OF VIEW. US ENDOSCOPY RECEIVED A REPORT REGARDING A COLONOSCOPY PROCEDURE IN WHICH THE ENDORINGS DEVICE BECAME DETACHED FROM THE ENDOSCOPE DURING A PROCEDURE. WHEN WITHDRAWING THE ENDOSCOPE FROM THE PATIENT THE ENDORINGS BECAME DETACHED AT THE RECTUM. THE DEVICE WAS REMOVED FROM THE PATIENT DIGITALLY. THERE WAS NO REPORTED HARM TO THE PATIENT. THE MANUFACTURER OF THIS DEVICE HAS BEEN INFORMED OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT MAY BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95173 ENDORINGS ENDORINGS FED ENDOAID, LTD. E103 10300006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention