BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCHOICE

    MDR report key: 7276141 · Received February 15, 2018

    Report

    Report Number
    MW5075303
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 14, 2018
    Manufacturer
    BOSTON SCIENTIFIC/ ENDOCHOICE
    Product Code
    FCH
    UDI-DI
    00840253113337
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOCHOISE COMPLIANCE ENDOKIT HEDGEHOG DUAL END BRUSH REF CEK-721-20 LOT 205644 EXP 08/2019. BRUSH END BROKE OFF AND REMAINED LODGED IN ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117329 ENDOCHOICE TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS FCH BOSTON SCIENTIFIC/ ENDOCHOICE 205644 205644 00840253113337

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention