BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 4215151 · Received October 30, 2014

    Report

    Report Number
    2955842-2014-05574
    Event Type
    Death
    Date Received
    October 30, 2014
    Date of Event
    June 7, 2012
    Report Date
    October 7, 2014
    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

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THE NAME OF THE MEDICAL CENTER WHERE THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. IN ADDITION, THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL DOCUMENT CLAIMS THAT THE PATIENT DEVELOPED OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATIONS 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 WHO UNDERWENT A DA VINCI ROBOTICALLY-ASSISTED MINI TVR (TRICUSPID VALVE REPAIR) PROCEDURE VIA RIGHT THORACOTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT PROVIDED CLAIMS THAT AS A RESULT OF THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS AND DAMAGES INCLUDING BUT NOT LIMITED TO RESPIRATORY FAILURE AND HD INSTABILITY, PORTAL VEIN THROMBOSIS WITH ELEVATED BILIRUBIN, AND EVENTUALLY, DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697486 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

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