BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7214939 · Received January 23, 2018

    Report

    Report Number
    MW5074768
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 10, 2018
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAPLER FAILED TO CALIBRATE AFTER NEW STAPLE RELOAD WAS INSTALLED AND STAPLER WAS RE-INSERTED IN ROBOT ARM. ONCE STAPLER WAS REMOVED AFTER FAILURE TO CALIBRATE, STAPLER JAWS WOULD NOT OPEN TO RELEASE THE NEW STAPLE RELOAD. STAPLER WAS TESTED AFTER PROCEDURE AND WAS COMPLETED WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56131 INTUITIVE SURGICAL INC. DA VINCI XI ENDOWRIST 45 STAPLER NAY INTUITIVE SURGICAL INC. DA VINCI XI T10171012

    Patients

    Seq Age Sex Outcome Treatment
    1