BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4043835 · Received June 19, 2014

    Report

    Report Number
    4043835
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INTUITIVE MEDICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FACILITY HAVING CONTINUED ISSUES WITH THE DAVINCI STERILE CAMERA ARM DRAPES-UPON PREPARING THE DRAPE FOR USE ON THE STERILE FIELD, THE TECHNICIAN HAS DISCOVERED HOLES IN THE PAPER HEAT SHIELD PORTION LOCATED JUST ABOVE THE PLASTIC SCOPE HOLDER PIECE. THIS HAS OCCURRED IN EVERY TYPE OF PACKAGING: 3-ARM ACCESSARY KIT, 4-ARM ACCESSARY KIT AND THE SINGLE CAMERA ARM DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361385 * SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE MEDICAL, INC. * D140425, D132836A, D133435
    361443 * SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE MEDICAL, INC. * D140645A, D140295, D132895A
    361444 * SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE MEDICAL, INC. * 132055

    Patients

    Seq Age Sex Outcome Treatment
    1 *