BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2895808 · Received January 3, 2013

    Report

    Report Number
    2955842-2013-00040
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2010
    Report Date
    December 4, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 ISI CONTACTED DR. (B)(6) THE SURGEON WHO HAD PROVIDED THE INITIAL PATIENT CARE. ON (B)(6) 2013, DR. (B)(6) INFORMED HE WOULD SEEK LEGAL ADVICE PRIOR TO OPENING DIALOGUE FOR THIS COMPLAINT. A REVIEW OF SYSTEM LOGS FOR THE DA VINCI S SYSTEM USED IN THE CASE ON THE EVENT DATE ((B)(6) 2010) SHOWED NO ERRORS DURING THE PROCEDURE. THE ROOT CAUSE OF THE REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS ALLEGING A PATIENT WAS BURNED AND THE SYSTEM TORE TISSUES OF THE PATIENT'S RECTUM, CAUSING A FISTULA WHICH REQUIRED SUBSEQUENT HOSPITALIZATIONS AND MULTIPLE SURGICAL PROCEDURES. IT IS ALLEGED THAT THE PATIENT REMAINS INJURED TODAY AS A RESULT. IT IS ALLEGED THAT THE PATIENT IS PERMANENTLY AND SERIOUSLY INJURED. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED SEVERE PHYSICAL HARM AND SEVERE EMOTIONAL DISTRESS. THE DATE OF THE ORIGINAL PROCEDURE WAS (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2906 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES