BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDORINGS

    MDR report key: 5041766 · Received August 27, 2015

    Report

    Report Number
    3010704463-2015-00003
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 27, 2015
    Manufacturer
    ENDOAID LTD
    Product Code
    FED
    PMA / PMN Number
    K133359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    THE ENDORINGS 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 RETRIEVAL. THE USER REPORTED THE PATIENT HAD A TIGHT COLON AND THE DOCTOR FELT RESISTANCE DURING USE. THE USER ALSO REPORTED THAT A NON COMPATIBLE ENDORINGS MODEL WAS ASSEMBLED- AN ADULT ENDORINGS MODEL E101 WAS ASSEMBLED ON A PEDIATRIC SCOPE OLYMPUS PCF-190 (TOO BIG THEREFORE DETACHED) INSTEAD OF E101S AS DESCRIBED IN THE IFU. INFO FOUND IN THE INSTRUCTIONS FOR USE INCLUDES: DO NOT USE THE DEVICE IN PATIENTS WITH KNOWN STRICTURES OR OTHER CONDITIONS THAT MAY PRESENT WITH NARROWED COLONIC SEGMENTS; THE ENDORINGS DEVICE SHOULD ONLY BE USED WITH COMPATIBLE COLONOSCOPES; THE COMPATIBILITY CHART LISTS 'ENDORINGS DEVICE E101S- FOR USE WITH SLIM COLONOSCOPE -INCLDG OLYMPUS SLIM PCF - 190L SERIES. THE USER WAS PROVIDED WITH IN-SERVICE TRAINING PRIOR TO THE DEVICE USE, AND HAD SELECTED THE APPROPRIATE ENDORINGS DEVICE SIZE FOR OTHER PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569895 ENDORINGS ENDORINGS FED ENDOAID LTD E101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other