BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGER WAVEGUIDE

    MDR report key: 5398189 · Received January 29, 2016

    Report

    Report Number
    5398189
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 22, 2016
    Manufacturer
    INVUITY, INC.
    Product Code
    FDG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING BREAST SURGERY, THE RESIDENT NOTICED THE LIGHTED BREAST RETRACTOR THAT HAD BEEN WORKING PRIOR WAS NOT WORKING PROPERLY. UPON FURTHER INSPECTION, IT WAS OBSERVED THAT A PIECE OF THE WAVEGUIDE HAD BROKEN OFF. THE BROKEN PIECE HAD FALLEN INTO THE PATIENT, BUT WAS REMOVED. THERE WAS NO HARM TO PATIENT AND THIS IS A NEAR MISS WITH POTENTIAL FOR HARM IF STAFF HAD NOT FOUND BROKEN PLASTIC PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58090 EIGER WAVEGUIDE RETRACTOR, FIBEROOPTIC FDG INVUITY, INC. AB15102402

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NONE KNOWN