BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGR WAVEGUIDE, WIDE/ANGLE

    MDR report key: 2661473 · Received July 18, 2012

    Report

    Report Number
    2661473
    Event Type
    Malfunction
    Date Received
    July 18, 2012
    Date of Event
    June 18, 2012
    Report Date
    July 18, 2012
    Manufacturer
    INVUITY, INC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE TIP OF THE LIGHTED RETRACTOR BROKE INTO TWO PIECES AFTER IT WAS REMOVED FROM THE PATIENT BUT WHILE STILL ON THE FIELD. NO X-RAY WAS TAKEN BECAUSE IT IS NOT X-RAY DETECTABLE. ALL PIECES APPEAR TO BE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIGR WAVEGUIDE, WIDE/ANGLE TIP JOL INVUITY, INC 102521 12020605

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR