BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4429207 · Received January 16, 2015

    Report

    Report Number
    2955842-2015-00106
    Event Type
    Death
    Date Received
    January 16, 2015
    Date of Event
    May 3, 2013
    Report Date
    December 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO INDICATION 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. A MEDICAL REVIEW HAS BEEN PERFORMED BY A PERSON QUALIFIED TO MAKE A MEDICAL JUDGMENT (SURGEON) BASED ON THE AVAILABLE INFORMATION PROVIDED. THE MEDICAL REVIEWER INDICATED THAT THE CARDIO-PULMONARY ARREST DUE TO ASPIRATION WAS A COMPLICATION THAT WAS NOT CAUSED BY THE DA VINCI SURGICAL SYSTEM AND WAS LIKELY DUE TO OTHER MEDICAL FACTORS THAT OCCURRED POST-OPERATIVELY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS 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 NEPHRECTOMY PROCEDURE FOR A LEFT RENAL MASS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 50 ML. POST-OPERATIVELY, THE PATIENT WAS DOING FINE UNTIL THE MORNING OF (B)(6) 2013 WHEN HER HEMOGLOBIN WAS FOUND TO HAVE DROPPED FROM 7.8 TO 5.5, AND SHE SUBSEQUENTLY BECAME HYPOTENSIVE. HER ANTICOAGULATION, WHICH SHE HAD BEEN ON FOR HER ATRIAL FIBRILLATION, WAS STOPPED. A CT SCAN WAS PERFORMED AND SHOWED AN ANTERIOR WALL HEMATOMA AS WELL AS A HEMATOMA IN THE SURGICAL BED. SELECTIVE EMBOLIZATION WAS UNDERTAKEN OF THE INTERNAL MAMMARY ARTERY, AND THE PATIENT WAS TRANSFERRED BACK TO THE FLOOR AND RECEIVED FOUR UNITS OF PACKED CELLS. SHE INITIALLY RESPONDED, BUT AFTER MIDNIGHT ON (B)(6) 2013 SHE BECAME ACUTELY MORE HYPOTENSIVE AND HER URINE OUTPUT DECREASED. SHE WAS TRANSFERRED TO THE SURGICAL ICU FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT RECEIVED FOUR MORE UNITS OF PACKED RED CELLS AND 4 UNITS OF FRESH FROZEN PLASMA. THE PATIENT EXPERIENCED EMESIS WHICH WAS IMMEDIATELY FOLLOWED BY CARDIAC/RESPIRATORY ARREST. ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOL WAS FOLLOWED AND CPR CONDUCTED FOR 13 MINUTES. THE PATIENT WAS INTUBATED, AND PARTICULATE MATTER AND GREEN FLUID WERE NOTED. A CONCERN FOR ASPIRATION WAS ALSO NOTED. THE PATIENT WAS STABILIZED AND RETURNED TO INTERVENTIONAL RADIOLOGY FOR A REPEAT ANGIOGRAM. THE LEFT SUPERFICIAL EXTERNAL PUDENDAL ARTERY, LEFT INFERIOR EPIGASTRIC ARTERY, AND LEFT DEEP CIRCUMFLEX ILIAC ARTERY WERE EMBOLIZED. LATER IN THE AFTERNOON OF (B)(6) 2013, THE PATIENT BEGAN TO EXPERIENCE CRITICAL EKG CHANGES. FOLLOWING ANOTHER FAMILY CONFERENCE REGARDING HER CARE, THE PATIENT WAS EXTUBATED AT 7:50 PM. SHE EXPIRED AT 10:08 PM. PER THE DEATH CERTIFICATE DATED (B)(6) 2013, THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST AS A RESULT OF ASPIRATION. THE MANNER OF DEATH WAS NOTED AS NATURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39149 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L| R