BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3638244 · Received February 20, 2014

    Report

    Report Number
    2955842-2014-01028
    Event Type
    Death
    Date Received
    February 20, 2014
    Date of Event
    June 25, 2012
    Report Date
    January 22, 2014
    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 POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY EXPIRED DUE TO CARDIOPULMONARY COLLAPSE.

    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 BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR PELVIC MASS AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012 DUE TO CARDIOPULMONARY COLLAPSE. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT ALONG WITH FOLLOW-UP HOSPITAL REPORTS. ACCORDING TO THE DA VINCI SURGERY OPERATIVE REPORT DATED (B)(6) 2012, THE PATIENT HAS A HISTORY OF A LIVER TRANSPLANT AND CROHN'S DISEASE. DURING SURVEILLANCE OF HER LIVER TRANSPLANT IN (B)(6) 2011, AN ABDOMINAL MRI REVEALED SHE HAD A LOBULATED, SEPTATED CYSTIC MASS IN THE LEFT ADNEXAL REGION THAT WAS NOT SEEN IN PRIOR EXAMS. AN ULTRASOUND ALSO REVEALED THAT THE PATIENT WAS FOUND TO HAVE A COMPLEX ADNEXAL MASS MEASURING 4.5 CM X 3.3 CM WITH CYSTIC AND SOLID COMPONENTS. A DECISION WAS MADE TO PROCEED WITH THE BILATERAL SALPINGO-OOPHORECTOMY. RISKS, BENEFITS AND ALTERNATIVES WERE DISCUSSED WITH THE PATIENT. THE PATIENT ALSO HAD A SIGNIFICANT PULMONARY HISTORY (COPD) AND A BRONCHOSCOPY WAS PERFORMED AT THE BEGINNING OF THE DA VINCI SURGICAL PROCEDURE. AFTER THE DA VINCI ROBOTIC CAMERA WAS INSERTED, DIFFUSE ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL ALONG THE PATIENT'S RIGHT SIDE AS WELL AS IN THE LEFT UPPER QUADRANT AND THE MIDLINE WERE OBSERVED. DURING THE EXTENSIVE LYSIS OF ADHESIONS, A SMALL ENTEROTOMY WAS MADE IN THE SMALL BOWEL. ONCE ENOUGH ADHESIONS WERE TAKEN DOWN FOR ALL THE DA VINCI PORTS TO BE PLACED, THE DA VINCI SYSTEM WAS THEN DOCKED TO THE PATIENT. THE UNINTENTIONAL ENTEROTOMY WAS REPAIRED ROBOTICALLY. THE SURGERY CONTINUED WITH NO ADDITIONAL COMPLICATIONS, OTHER THAN THE ENTEROTOMY TO THE SMALL BOWEL THAT OCCURRED BEFORE THE DA VINCI SYSTEM WAS DOCKED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ACCORDING TO A FOLLOWUP INPATIENT CONSULT NOTE DATED (B)(6) 2012, THE PATIENT HAD AN ACUTE RESPIRATORY ACIDOSIS AND METABOLIC ACIDOSIS POST EXTUBATION. THE PATIENT ALSO HAD COMPLAINTS OF PERSISTENT LEFT UPPER QUADRANT PAINT. AN OPERATIVE REPORT DATED (B)(6) 2012 INDICATED THAT THE PATIENT WAS BROUGHT INTO INTENSIVE CARE UNIT (ICU). CT SCAN REVEALED MULTIPLE LOCULATIONS AND FLUID COLLECTIONS IN THE UPPER ABDOMEN UNDER THE LEFT HEMIDIAPHRAGM AS WELL AS UNDERNEATH THE STOMACH. THE PATIENT ALSO HAD A LARGE, ABOUT 13 CM, ABSCESS IN THE PELVIS WITH A SMALL AREA OF BOWEL LEAK. THE PATIENT HAD SOME RESPIRATORY DECOMPENSATION IN THE SURGICAL ICU WITH SOME ASPIRATION AND WAS INTUBATED PRIOR TO BRINGING HER BACK TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS AS WELL AS ENTEROTOMY REPAIR X3. THE 3 ENTEROTOMIES THAT WERE NOTED WERE LIKELY PATHOLOGIC SECONDARY TO PATIENT'S HISTORY OF CROHN'S DISEASE. NO INTRA-SURGICAL COMPLICATIONS WERE NOTED AND THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO A FOLLOWUP INPATIENT CONSULT NOTE DATED (B)(6) 2012, THE PATIENT WAS IN CRITICAL CONDITION WITH SEPSIS AND RESPIRATORY FAILURE. ON (B)(6) 2012, A CHEST X-RAY REVEALED PNEUMONIA AND THE PATIENT WAS TRANSFERRED TO SURGICAL ICU. DURING HER SICU STAY, THE PATIENT WAS TREATED FOR SEPSIS WITH ONGOING HYPOTENSION AND THE PATIENT EVENTUALLY EXPIRED ON (B)(6) 2012 DUE TO CARDIOPULMONARY COLLAPSE. THE PROVIDED MEDICAL RECORDS DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION WITH THE DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107571 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| L| R