BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 5792290 · Received July 13, 2016

    Report

    Report Number
    1528319-2016-00019
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    May 9, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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 FORCEPS DEVICE. THE RETRIEVAL RESULTED IN AN HOUR DELAY TO THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE DEVICE DETACHMENT, NOR AS A RESULT OF THE DEVICE RETRIEVAL. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED A SLIM COLONOSCOPE WAS USED FOR THE PROCEDURE WITH THE ENDORINGS MODEL E102 IN ERROR. INFORMATION FOUND IN THE ENDORINGS INSTRUCTIONS FOR USE(IFU) INCLUDES 'THE ENDORINGS DEVICE SHOULD ONLY BE USED WITH COMPATIBLE COLONOSCOPES.' THE COMPATIBILITY CHART INCLUDED IN THE IFU LISTS 'ENDORINGS MODEL E103 - SLIM ADULT COLONOSCOPES - 11.5-13.0 MM DISTAL END DIAMETER'. THE USER HAD BEEN PROVIDED WITH IN-SERVICE TRAINING, AND HAD SELECTED THE APPROPRIATE ENDORINGS DEVICE SIZE FOR OTHER PROCEDURES. 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
    444030 ENDORINGS ENDORINGS FED ENDOAID, LTD. E102 10200027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention