BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS DEVICES

    MDR report key: 4901129 · Received July 7, 2015

    Report

    Report Number
    1528319-2015-00019
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, 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 ENDOSCOPIC FIELD OF VIEW. THE USER FACILITY REPORTED DISCOVERING SEVERE DIVERTICULAR DISEASE AND A VERY TIGHT/NARROW COLON DURING USE OF THE ENDORINGS DEVICE FOR A SCREENING COLONOSCOPY ON A FEMALE PATIENT ((B)(6)) WITH PREVIOUS HISTORY OF ABDOMINAL SURGERY. THE ENDOSCOPE WAS WITHDRAWN AND THE ENDORINGS DEVICE WAS REMOVED. THE ENDOSCOPE WAS THEN REINSERTED AND A PERFORATION WAS DETECTED. THE PATIENT WAS HOSPITALIZED AND TREATED LAPAROSCOPICALLY, AND IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439305 ENDORINGS DEVICES ENDORINGS FED ENDOAID, LTD. E101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention