BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3637897 · Received February 20, 2014

    Report

    Report Number
    2955842-2014-01019
    Event Type
    Death
    Date Received
    February 20, 2014
    Date of Event
    May 20, 2012
    Report Date
    December 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEATH. NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS REPORTED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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. THE DATE OF THE PATIENT'S DEMISE IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012 AND NO REPORTED MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED A PERFORATED BOWEL AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND DIED. HOWEVER INFORMATION LEADING TO THE PATIENT'S DEATH WAS NOT PROVIDED TO ISI.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR MEDICAL RECORDS. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER THE LEGAL DOCUMENT, THE PATIENT SUFFERED A PERFORATED BOWEL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108715 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death