BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 4838158 · Received June 5, 2015

    Report

    Report Number
    MW5043038
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 5, 2015
    Manufacturer
    ENDOAID LTD
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ENDOSCOPE NEAR THE SIGMOID COLON. THE PHYSICIAN RETRIEVED THE DEVICE WITH A RAPTOR GRASPING DEVICE. THERE WAS A DELAY IN PROCEDURE OF APPROX 3-5 MINUTES FOR THE RETRIEVAL. THERE WAS NO HARM TO THE PT AS A RESULT OF THE DEVICE DETACHMENT FROM THE SCOPE, NOR AS A RESULT OF THE DEVICE RETRIEVAL. THE USER ALSO REPORTED THE ENDORINGS DEVICE HAD DETACHED FROM THE ENDOSCOPE BECAUSE THE WRONG SIZE DEVICE (TOO LARGE) HAD BEEN SELECTED FOR USE WITH THE ENDOSCOPE (FUJI MODEL # EC-530LS2). THERE WAS NO REPORT OF PRODUCT DEFECT OR MALFUNCTION. THE DEVICE WAS DISPOSED OF AFTER RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366390 ENDORINGS ENDORINGS FED ENDOAID LTD E101 10100019

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention