BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3171112 · Received June 14, 2013

    Report

    Report Number
    2955842-2013-02180
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    October 3, 2012
    Report Date
    May 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AND INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012, AND NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT EXPERIENCED SEVERE COMPLICATIONS AND REQUIRED A SECOND OPERATION AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SIGMOID COLECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED: IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT SUFFERED SEVERE COMPLICATIONS, INCLUDING, BUT NOT LIMITED TO, AN ANASTOMOSIS LEAK REQUIRING A SECOND OPERATION. IN ADDITION THE LEGAL COMPLAINT STATES THAT THE SURGICAL EQUIPMENT MANUFACTURED BY ISI MALFUNCTIONED, CAUSING AND RESULTING IN SEVERE INJURIES AND THAT THE PATIENT WAS HURT AND INJURED IN HIS HEALTH, STRENGTH AND ACTIVITY, SUSTAINING INJURY TO HIS BODY AND PERSON THIS WAS REPORTED TO HAVE CAUSED THE PATIENT GREAT MENTAL, PHYSICAL, AND NERVOUS PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271705 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES