BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 5765241 · Received July 1, 2016

    Report

    Report Number
    2955842-2016-00480
    Event Type
    Death
    Date Received
    July 1, 2016
    Date of Event
    August 27, 2012
    Report Date
    June 6, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. BASED ON THE AVAILABLE SYSTEM LOG INFORMATION, NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. EACH REUSABLE (MULTI-USE) INSTRUMENT USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WERE USED IN SUBSEQUENT SURGICAL PROCEDURES WITHOUT ANY REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI-ASSISTED MITRAL VALVE REPLACEMENT PROCEDURE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE SURGEON INJURED THE DOME OF THE PATIENT'S LEFT ATRIUM AND THE PATIENT SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE ARE UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2012 FOR A HISTORY OF ATRIAL FIBRILLATION AND MITRAL STENOSIS. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT. BASED ON THE LEGAL DOCUMENTS PROVIDED BY THE PLAINTIFF'S ATTORNEY, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PLAINTIFF'S ATTORNEY CLAIMS THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ALLEGEDLY CAUSED A TEAR TO THE DOME OF THE LEFT ATRIUM, CAUSING SEVERE PERMANENT LUNG DAMAGE AND DEATH ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENTS PROVIDED, THE PATIENT PASSED AWAY FROM ADULT RESPIRATORY DISTRESS SYNDROME DUE TO MITRAL STENOSIS. THE PLAINTIFF'S ATTORNEY ALSO ALLEGES THAT THE SURGEON FAILED TO CONVERT TO OPEN SURGERY AFTER HE CAUSED THE TEAR TO THE ATRIUM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420258 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R