BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S

    MDR report key: 2900760 · Received January 3, 2013

    Report

    Report Number
    2900760
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY HALFWAY THROUGH THE PROCEDURE THE C-ARM DRAPE BEGAN STICKING MAKING IT NOT RESPOND CORRECTLY TO MOVEMENT - NO PATIENT HARM BUT POTENTIAL - APPEARED TO BE LOT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3377 DA VINCI S SYSTEM,SURGICAL NAY INTUITIVE SURGICAL 420015 D122295A

    Patients

    Seq Age Sex Outcome Treatment
    1