BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3898268 · Received June 26, 2014

    Report

    Report Number
    2955842-2014-03942
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    September 3, 2008
    Report Date
    May 27, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K021036
    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 FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DA VINCI SURGICAL SYSTEM (SERIAL (B)(4)) WAS RETURNED TO ISI AND UPGRADED PRIOR TO ISI RECEIVING KNOWLEDGE OF THE REPORTED EVENT INVOLVED WITH THIS COMPLAINT. THEREFORE, THE DA VINCI SURGICAL SYSTEM (SERIAL (B)(4)) HAS NOT BEEN EVALUATED IN RELATION TO THE REPORTED EVENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. 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 SI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 2 MONTHS LATER DUE TO ACUTE RESPIRATORY FAILURE.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGEMENT DEPARTMENT. THE SITE'S RISK MANAGER VERIFIED THAT THE PATIENT HAD A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2008 AND THE DA VINCI SURGICAL SYSTEM WAS NOT USED DURING THE PROCEDURE. THE RISK MANAGER WAS UNABLE TO PROVIDE THE NAME OF THE SURGICAL PROCEDURE. THE RISK MANAGER STATED THAT SHE COULD NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DUE TO PATIENT PRIVACY REGULATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 ESOPHAGOGASTRECTOMY FOR ESOPHAGEAL ADENOCARCINOMA ON (B)(6) 2008. A COMBINATION OF STANDARD LAPAROSCOPIC AND ROBOTIC ASSISTED LAPAROSCOPY WAS PERFORMED. THE SURGEON WENT BACK AND FORTH BETWEEN ROBOTIC ASSISTED AND NON-ROBOTIC LAPAROSCOPIC TECHNIQUE DEPENDING UPON WHICH TASKS WERE BEING ACCOMPLISHED. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUPPLEMENTAL HOSPITAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING ANY PORTION OF THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE BARRETT'S ESOPHAGUS CHANGES. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, THERE WERE ADHESIONS IN THE UPPER ABDOMEN, LEFT ABDOMEN AND RIGHT ABDOMEN. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT UNDERWENT AN ABDOMINAL X-RAY AFTER AN INCORRECT NEEDLE COUNT WAS OBSERVED BY THE SURGICAL STAFF. THE X-RAY WAS NEGATIVE FOR RETAINED SURGICAL INSTRUMENTATION. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON POST-OPERATIVE DAY 2 ((B)(6) 2008), THE PATIENT WAS ASSESSED FOR TACHYCARDIA, SHORTNESS OF BREATH, AND COMPLAINTS OF CHEST PAIN AND DISCOMFORT WORSENING WITH BREATHING AND COUGHING. THE PATIENT WAS DIAGNOSED WITH ATRIAL FIBRILLATION AND A PULMONARY EMBOLISM. THE PATIENT WAS STARTED ON ANTICOAGULATION THERAPY. ON (B)(6) 2008, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REPAIR OF WOUND DEHISCENCE AT THE SUPRAUMBILICAL PORT (EXTRACTION) SITE. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT DID WELL DURING REPAIR OF THE WOUND DEHISCENCE SURGERY. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH COMPLAINTS OF HEMATEMESIS, ABDOMINAL PAIN, AND DISTENSION. A CT-SCAN REVEALED A HIGH-GRADE SMALL BOWEL OBSTRUCTION. ON (B)(6) 2008, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD). THE TEST REVEALED A GASTRIC ULCER AND AN ANASTOMOTIC ULCER WITH BLEEDING. ON (B)(6) 2008 THE PATIENT DEVELOPED SHORTNESS OF BREATH AND HAD ATELECTASIS, PLEURAL EFFUSION AND PNEUMONIA BASED ON CHEST X-RAY FINDINGS. HE ALSO DEVELOPED ACUTE RENAL FAILURE. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED SHOWING NO LEAKAGE BUT BLEEDING WAS OBSERVED FROM THE ANASTOMOSIS SITE. AN ECHOCARDIOGRAM SHOWED NORMAL LEFT VENTRICULAR FUNCTION. THE PATIENT WAS TREATED WITH INTENSIVE ANTIBIOTIC AND PULMONARY THERAPY. ON (B)(6) 2008, A BRONCHOSCOPY CONFIRMED THAT THE PATIENT HAD PNEUMONIA. ON (B)(6) 2008, A BARIUM SWALLOWING STUDY WAS PERFORMED WHICH CONFIRMED ASPIRATION FROM ALL CONSISTENCIES OF ORAL INTAKE. THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO LONG-TERM CARE. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT UNDERWENT AN UNSPECIFIED OPERATION ON (B)(6) 2008. NO MEDICAL RECORDS BETWEEN (B)(6) 2008 WERE PROVIDED. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2008 FROM ASPIRATION PNEUMONIA. THE PATIENT'S DEATH CERTIFICATE STATES THAT THE CAUSE OF DEATH WAS ACUTE RESPIRATORY FAILURE DUE TO OR AS A CONSEQUENCE OF ASPIRATION AND DYSPHAGIA S/P GASTROESOPHAGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375113 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R