BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3150836 · Received June 6, 2013

    Report

    Report Number
    2955842-2013-02026
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    February 3, 2010
    Report Date
    May 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED INJURY. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2010. AT THIS TIME, IT IS UNKNOWN HOW OR WHEN THE PATIENT'S REPORTED INJURY ACTUALLY OCCURRED. ACCORDING TO THE LEGAL FILING, IT WAS NOTED IN THE PATIENT'S MEDICAL RECORDS FOR THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2010, THAT HER OVARIES WERE NORMAL AND THEIR VASCULAR SUPPLY WAS UNINTERRUPTED. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE RISK MANAGEMENT DEPARTMENT OF THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL FILING CLAIMS THAT AT SOME POINT DURING THE DA VINCI SI SURGICAL PROCEDURE THE PATIENT'S RIGHT OVARY WAS REMOVED WITHOUT HER CONSENT OR KNOWLEDGE. THE PATIENT REPORTEDLY DISCOVERED THAT HER RIGHT OVARY WAS MISSING AFTER UNDERGOING A SURGICAL PROCEDURE ON (B)(6) 2013 TO REMOVE HER LEFT OVARY. AFTER COMPLETION OF THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INFORMED THE PATIENT THAT THERE WAS SCAR TISSUE WHERE HER RIGHT OVARY SHOULD HAVE BEEN, AND THAT THE RIGHT OVARY WAS GONE. THE LEGAL FILING INDICATES THAT THE ONLY SURGICAL PROCEDURE THE PATIENT HAD PRIOR TO (B)(6) 2013, WAS THE DA VINCI PROCEDURE PERFORMED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251003 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

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