BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3728684 · Received April 7, 2014

    Report

    Report Number
    2955842-2014-01989
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON REPORTEDLY INFORMED AN ISI CLINICAL SALES REPRESENTATIVE (CSR) THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI CHOLECYSTECTOMY PROCEDURE INVOLVED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON OR CSR. ISI HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE SITE'S RISK MANAGEMENT DEPARTMENT TO INQUIRE ABOUT THE PATIENT'S AUTOPSY REPORT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER INDICATED THAT THE PATIENT'S AUTOPSY REPORT WAS STILL NOT AVAILABLE. THE RISK MANAGER INDICATED THAT SHE SPOKE TO THE CORONER AND WAS INFORMED THAT THE PATIENT'S DEATH WAS RELATED TO HYPERTENSIVE ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE. ACCORDING TO THE RISK MANAGER, THE CORONER ALSO REPORTEDLY DID NOT FIND ANY INTERNAL ISSUES WITHIN THE PATIENT THAT WAS RELATED TO THE DA VINCI SURGICAL PROCEDURE. THE RISK MANAGER STATED THAT THE PATIENT'S DEATH WAS ALL CORONARY.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEMISE. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. 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)(4) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE AND THEN PASSED AWAY ON POST-OPERATIVE DAY 2. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPIRED ON POST-OPERATIVE DAY 2. NO ISSUES WERE REPORTED TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE PATIENT'S MEDICAL RECORDS AND THE OPERATIVE REPORT. ACCORDING TO THE RISK MANAGER, THE PATIENT HAD A HISTORY OF CARDIAC DISEASE AND CORONARY ARTERY DISEASE. HE WAS A 2 PACK/DAY SMOKER. ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE HOSPITAL FOR COMPLAINTS OF ABDOMINAL PAIN AND CHEST PAIN. IMAGING WAS PERFORMED AND IT WAS DETERMINED AT THE TIME THAT THE PATIENT NEEDED A CHOLECYSTECTOMY. THE PATIENT REPORTEDLY TOLD THE SURGEON THAT HE HAD KNOWN THAT HE HAD GALL STONES FOR 3 YEARS. BASED ON THE OPERATIVE REPORT, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY. THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POST-OPERATIVE DAY 1 ((B)(6) 2014). THE RISK MANAGER INDICATED THAT AT THE TIME OF DISCHARGE, THE PATIENT'S REPEAT LABS LOOKED GOOD. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT'S WIFE INDICATED THAT HE GOT UP FROM BED DURING THE NIGHT AND THEN FELL OVER. THE PATIENT UNDERWENT CPR FOR ABOUT 60 MINUTES BEFORE HE ARRIVED AT THE HOSPITAL ON (B)(6) 2014 AT 12:17 AM. THE PATIENT WAS UNABLE TO BE RESUSCITATED. HIS ADMITTING DIAGNOSIS WAS ACUTE CARDIAC ARREST. THE RISK MANAGER INDICATED THAT AN AUTOPSY HAS BEEN PERFORMED BY A CORONER BUT THE AUTOPSY RESULTS ARE NOT CURRENTLY AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209040 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death