BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHREX VIDEO SYSTEM

    MDR report key: 6053722 · Received October 21, 2016

    Report

    Report Number
    MW5065582
    Event Type
    Other
    Date Received
    October 21, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ARTHREX
    Product Code
    FWL
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT SHOULDER SURGERY. ARTHREX CAMERA AND LIGHT BOX MOMENTARILY MALFUNCTIONED. APPROXIMATELY 75 SECONDS AFTER CASE START, VIDEO SOURCE AND LIGHT SOURCE WERE LOST. ARTHREX REPRESENTATIVE WAS IN ROOM AND UNABLE TO REGAIN LIGHT SOURCE. VIDEO WAS REGAINED AND HEADLIGHT BOX WAS USED FOR LIGHT SOURCE. PRINTER THEN PRINTED PREVIOUS CASE OVERTOP OF CURRENT CASE ON SAME PAPER WITH BOTH PATIENTS INFORMATION OVERLAYING EACH OTHER. THERE WAS NO INJURY TO THE PATIENT. OPERATING ROOM LEADERSHIP REFERRED THE SITUATION TO THE ARTHREX REPRESENTATIVE FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697421 ARTHREX VIDEO SYSTEM ARTHREX VIDEO SYSTEM FWL ARTHREX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other