BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER

    MDR report key: 12016315 · Received June 17, 2021

    Report

    Report Number
    12016315
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    February 12, 2020
    Report Date
    June 9, 2021
    Manufacturer
    INVUITY, INC.
    Product Code
    FSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER PIECE. AFTER TURNING THE LIGHT SOURCE ON DURING SURGERY, THE ADAPTER PIECE MALFUNCTIONED AND BURNED THE SURGEON'S HAND. THE SURGEON DE-GOWNED AND REMOVED HIS GLOVES BUT DECLINED ANY FURTHER MEDICAL ASSISTANCE FOR THE BURN. IT WAS DEEMED APPROPRIATE TO REPLACE THE AFOREMENTIONED LIGHT ADAPTER. THE SURGEON SCRUBBED BACK INTO THE CASE, AS STERILITY WAS MAINTAINED THROUGHOUT THE INCIDENT. THE MALFUNCTIONING PIECE WAS EXAMINED BY THE CIRCULATOR AND CERTIFIED SURGICAL TECHNOLOGIST (CST), THEN GIVEN TO THE CIRCULATOR'S CLINICAL MANAGER FOR FURTHER INVESTIGATION/FOLLOW UP WITH THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915309 EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER LIGHT, SURGICAL, CARRIER FSZ INVUITY, INC. NARROW / FLAT

    Patients

    Seq Age Sex Outcome Treatment
    1