BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 5007299 · Received August 13, 2015

    Report

    Report Number
    1528319-2015-00021
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    1

    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 REPORTED THE ENDORINGS DEVICE BECAME DETACHED FROM THE COLONOSCOPE, DURING WITHDRAWAL NEAR THE SIGMOID COLON. THE ENDORINGS DEVICE WAS RETRIEVED WITH A SNARE, WITH NO HARM TO THE USER AS A RESULT OF THE DEVICE DETACHMENT FROM THE SCOPE, NOR AS A RESULT OF THE DEVICE RETRIEVAL. THE USER REPORTED THE PATIENT HAD A TIGHT COLON AND THE DOCTOR FELT RESISTANCE DURING USE. THE USER ALSO REPORTED THE EVENT MAY HAVE OCCURRED DUE TO SELECTION OF AN ENDORINGS DEVICE WHICH WAS NOT APPROPRIATELY SIZED FOR USE WITH THE ENDOSCOPE (OLYMPUS PCF-190).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532449 ENDORINGS ENDORINGS FED ENDOAID, LTD. E101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other