BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL

    MDR report key: 5301961 · Received December 9, 2015

    Report

    Report Number
    5301961
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 8, 2015
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, 4 VESSEL SEALERS DID NOT WORK PROPERLY. THE BLADE WAS DEPLOYED INSIDE THE PATIENT AND WOULD NOT RETRACT; KEPT GIVING AN ERROR MESSAGE. LOT #: M10150714; EXP. 07/2017, M10150924; EXP. 09/2017, M10150924; EXP. 09/2017 AND M10150924; EXP. 09/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812411 INTUITIVE SURGICAL VESSEL SEALER NAY INTUITIVE SURGICAL 410322

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR