BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCUFF VISION

    MDR report key: 12728559 · Received October 29, 2021

    Report

    Report Number
    MW5105052
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    October 28, 2021
    Report Date
    October 28, 2021
    Manufacturer
    ARC / BODDINGTONS PLASTICS LTD
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, THE ENDOCUFF VISION BROKE APART IN PATIENT. ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616892 ENDOCUFF VISION ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED ARC / BODDINGTONS PLASTICS LTD 072108

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention