BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI LARGE CLIP APPLIER

    MDR report key: 14787566 · Received June 22, 2022

    Report

    Report Number
    MW5110447
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DAVINCI ROBOT LARGE ROBOT CLIP APPLIER WITH MANY LIVES LEFT DID NOT WORK WHEN NEEDED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090324 DAVINCI LARGE CLIP APPLIER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown