BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 5765183 · Received July 1, 2016

    Report

    Report Number
    2955842-2016-00479
    Event Type
    Injury
    Date Received
    July 1, 2016
    Report Date
    June 2, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE FOLLOWING INFORMATION IS UNKNOWN: WHAT HOSPITAL THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AT, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, AND WHAT DATE THE SURGICAL PROCEDURE WAS PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S SMALL INTESTINE WAS ALLEGEDLY INJURED WHILE UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE. HOWEVER, THE ROOT CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED ON 07/01/2016 WITH AN INCORRECT "DATE OF THIS REPORT" VALUE OF 06/01/2016. THIS FOLLOW-UP MDR IS BEING SUBMITTED WITH A CORRECTED "DATE OF THIS REPORT" VALUE OF 06/02/2016.

    Description of Event or Problem · 1

    ON 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG COMMENT STATING: OMG OMG OMG, ONE OF THE LADIES THAT WE GO TO CHURCH WITH JUST CALLED ASKING FOR PRAYERS FOR HER NIECE, (B)(6) JUST HAD SURGERY, A HYSTERECTOMY WITH THE ROBOT AND THEY KNICKED [SIC] HER SMALL INTESTINE [SIC] DURING THE PROCEDURE AND IT WAS THE SAME DOCTOR THAT DID IT TO ME!!!!!!! SHE IS IN INTENSIVE CARE......PLEASE PRAY. THE INTERNET BLOG COMMENT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATION. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: HTTP://UNPLUGTHEROBOT.BLOGSPOT.COM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419639 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention