BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KGH ROBOTIC PACK

    MDR report key: 10791919 · Received November 5, 2020

    Report

    Report Number
    10791919
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO INCISION, A ROBOTIC PACK WAS OPENED FOR THE CASE AND ALMOST ALL STERILE SUPPLIES WERE ALSO OPENED. WHILE SURGICAL TECHNOLOGIST (ST) WAS ARRANGING THE SUPPLIES, SHE NOTED A REDDISH/BROWN SPOT ON ONE OF THE TOWELS THAT WERE IN THE ROBOTIC PACK. ALL SUPPLIES WERE DISCARDED AND NEW WERE OPENED. THE TOWEL AND PACK PAPER WERE GIVEN TO SURGICAL MATERIALS IN THE OPERATING ROOM. THERE WAS NOT A DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257987 KGH ROBOTIC PACK GENERAL SURGERY TRAY LRO CARDINAL HEALTH 200, LLC 572035

    Patients

    Seq Age Sex Outcome Treatment
    1