BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGR

    MDR report key: 2852725 · Received November 13, 2012

    Report

    Report Number
    2852725
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    September 10, 2012
    Report Date
    November 13, 2012
    Manufacturer
    INVUITY
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE THE INVUITY WIDE ANGLE DISPOSABLE CONNECTOR WAS BROKEN IN TWO PIECES. THE PIECES ARE PLASTIC AND NOT X-RAY DETECTABLE. BOTH PIECES WERE RECOVERED AND NO DOUBT COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIGR LIGHT, SURGICAL, FIBEROPTIC JOL INVUITY 102521 12020202

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR