BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3667966 · Received March 7, 2014

    Report

    Report Number
    2955842-2014-01387
    Event Type
    Death
    Date Received
    March 7, 2014
    Date of Event
    May 12, 2009
    Report Date
    January 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE BLEEDING AND SUBSEQUENT DEMISE OF THE PATIENT. ISI HAS CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI ATTEMPTED TO REVIEW THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE; HOWEVER, IT HAS BEEN DISCOVERED THAT THE REPORTED DA VINCI SURGICAL SYSTEM WAS NOT YET INSTALLED AT THE SITE FOR THE REPORTED PROCEDURE DATE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, A COPY OF THE PATIENT'S OPERATIVE (OP) REPORT FOR THE DA VINCI SURGICAL PROCEDURE AND SUPPLEMENTAL HOSPITAL RECORDS WERE RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FROM THE PATIENT'S ATTORNEY. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S OP REPORT, THE PATIENT UNDERWENT A DA VINCI RADICAL PANCREATODUODENECTOMY, CHOLECYSTECTOMY AND GASTROJEJUNOSTOMY PROCEDURE FOR PANCREATIC ADENOCARCINOMA ON (B)(6) 2009. ISI PERFORMED A CAREFUL REVIEW OF THE OP REPORT AND FOUND THAT THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES DURING THE DA VINCI OPERATION AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. BASED ON THE INFORMATION CONTAINED IN THE PATIENT'S SUPPLEMENTAL MEDICAL RECORDS, AFTER THE DA VINCI SURGERY, THE PATIENT HAD A VERY PROLONGED HOSPITAL COURSE AFTER WHICH SHE EVENTUALLY EXPIRED. THE COMPLETE DETAILS OF HER HOSPITALIZATION WERE NOT PROVIDED; BUT CAN BE SUMMARIZED AS FOLLOWS: THE IMMEDIATE POST-OPERATIVE COURSE WAS UNEVENTFUL FOR APPROXIMATELY 10 DAYS AT WHICH TIME THE PATIENT DEVELOPED AN ILEUS AND AN ELEVATED WHITE BLOOD COUNT. A CT SCAN DEMONSTRATED SOME INFECTED FLUID COLLECTIONS NEAR THE PANCREATICOBILIARY AREA AS WELL AS INTO THE PELVIS. THE PATIENT EXPERIENCED DRAINAGE IN THESE AREAS AND THE PATIENT APPEARED TO HAVE IMPROVED; HOWEVER, 1 WEEK LATER ON (B)(6) 2008, THE PATIENT PASSED BLOOD IN HER DRAIN SITE AND SHE DEVELOPED HYPOTENSION. THE PATIENT WAS FOUND TO HAVE BLEEDING FROM HER GASTRODUODENAL ARTERY WHICH WAS EMBOLIZED BY INTERVENTIONAL RADIOLOGY SERVICES. THE PATIENT HAD PERSISTENT BILIARY FISTULA AND ILEUS. ON (B)(6) 2009 THE PATIENT HAD PLACEMENT OF A PERCUTANEOUS TRANSHEPATIC CHOLANGIO-CATHETER. THIS RESULTED IN A SMALL PSEUDOANEURYSM OF THE HEPATIC ARTERY. BECAUSE OF PERSISTENT BILIARY DRAINAGE THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009, AT WHICH TIME SHE WAS FOUND TO HAVE A COMPLETE BOWEL OBSTRUCTION DUE TO AN INCARCERATED MECKELS DIVERTICULUM, AND THIS WAS FELT TO BE THE SOURCE OF THE ORIGINAL INFECTED FLUID COLLECTIONS. THE TERMINAL ILEUM WAS RESECTED AND THE PATIENT REQUIRED A LOOP ILEOSTOMY. OVER THE NEXT SEVERAL DAYS THE PATIENT DEVELOPED SIGNS OF ISCHEMIC INJURY TO THE LIVER WITH COAGULOPATHY AND RISING BILIRUBIN. ON (B)(6) 2009 THE PATIENT DEVELOPED HYPOTENSION AND UNCONTROLLED BLEEDING FROM COAGULOPATHY, REQUIRING THE PATIENT TO UNDERGO MASSIVE BLOOD PRODUCT TRANSFUSION. ALSO AN R HEPATIC PSEDOANEURYSM RUPTURED WHICH WAS TREATED WITH A COVERED STENT. ACCORDING TO THE INFORMATION IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2009 A COMFORT TRACHEOSTOMY WAS PERFORMED. ON (B)(6) 2009 THE PATIENT DEVELOPED SEIZURE ACTIVITY WITH DECLINING MENTAL STATUS. THE PATIENT ALSO DEVELOPED A GRAM NEGATIVE BACTEREMIA FROM LINE SEPSIS WITH DECREASED BLOOD PRESSURE AND THEN DEVELOPED ATN. THIS DID NOT RESOLVE; HOWEVER, THE PATIENT EXPERIENCED MULTIORGAN FAILURE AND AGGRESSIVE MEASURES WERE WITHDRAWN AND THE PATIENT EXPIRED ON (B)(6) 2009. BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. THE PATIENT'S DEATH WAS LIKELY DUE TO A COMPLEX AND PROTRACTED COURSE THAT WAS RELATED TO A PREVIOUSLY UNDIAGNOSED INFECTED MECKEL'S DIVERTICULUM WHICH COMPLICATED AN OTHERWISE SUCCESSFUL ROBOTIC PROCEDURE. THERE WAS NO EVIDENCE OF ANY DA VINCI SURGICAL SYSTEM MALFUNCTION OR COMPLICATION THAT CAUSED THE PATIENT'S OUTCOME. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A PANCREATIC SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2009. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY DIED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140087 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| L