BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7689376 · Received July 13, 2018

    Report

    Report Number
    MW5078417
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 18, 2018
    Report Date
    July 2, 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

    SINGLE SITE MEDIUM LARGE CLIP APPLIER WITH INADEQUATE JAW CLOSURE TO COMPLETE "CLIP" SECURELY. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530425 INTUITIVE SURGICAL INC. DA VINCI SI 5MM SINGLE-SITE MEDIUM LARGE CLIP NAY INTUITIVE SURGICAL INC. DA VINCI SI N10170614

    Patients

    Seq Age Sex Outcome Treatment
    1