BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 20462939 · Received October 15, 2024

    Report

    Report Number
    MW5161091
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPOSE ABLE ROBOTIC FORCE BIPOLAR INSTRUMENT: ARTICULATING TIP OF INSTRUMENT BECAME UNHINGED. THIS WAS NOTED AT THE END OF THE CASE. NO HARM TO THE PATIENT. INSTRUMENT WILL BE SENT BACK TO INTUITIVE FOR REIMBURSEMENT. 5/12 LIVES REMAIN ON THIS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286774 DA VINCI XI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC XI K12240307 0169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown