BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS DEVICE

    MDR report key: 4826417 · Received June 5, 2015

    Report

    Report Number
    1528319-2015-00016
    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
    Distributor report
    Reporter Location
    NC, 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 APPROXIMATELY 3-5 MINUTES FOR THE RETRIEVAL. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE DEVICE DETACHMENT FROM THE SCOPE, NOR AS A RESULT OF THE DEVICE RETRIEVAL. THE USER 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 # (B)(4)). THERE WAS NO REPORT OF PRODUCT DEFECT OR MALFUNCTION. THE DEVICE WAS DISPOSED OF AFTER RETRIEVAL. 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 HAD BEEN PROVIDED WITH IN-SERVICE TRAINING, AND HAD SELECTED THE APPROPRIATE ENDORINGS DEVICE SIZE FOR OTHER PROCEDURES. WHEN PREPARING FOR THIS PROCEDURE, THE USER SELECTED ENDORINGS (B)(4)- FOR USE WITH WIDE ANGLE ADULT COLONOSCOPE, IN ERROR. THE USER WILL BE PROVIDED WITH ADDITIONAL IN SERVICE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366319 ENDORINGS DEVICE ENDORINGS FED ENDOAID, LTD. E101 10100019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention