BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 6282918 · Received January 27, 2017

    Report

    Report Number
    1528319-2017-00003
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 27, 2017
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 DESCENT FROM THE SIGMOID INTO THE COLON. THE PHYSICIAN RETRIEVED THE ENDORINGS DEVICE USING A RAT TOOTH FORCEPS. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE DEVICE DETACHMENT, NOR AS A RESULT OF THE DEVICE RETRIEVAL. 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
    66535 ENDORINGS ENDORINGS FED ENDOAID, LTD. E102 10200205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention