BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 6169632 · Received December 13, 2016

    Report

    Report Number
    1528319-2016-00030
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, 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 PROCEDURE IN WHICH THE ENDORINGS DEVICE BECAME DETACHED FROM THE ENDOSCOPE. THE PHYSICIAN RETRIEVED THE ENDORINGS DEVICE USING A RETRIEVAL DEVICE. 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
    819399 ENDORINGS ENDORINGS FED ENDOAID, LTD. E102 10200204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention