{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2014-00353", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140117", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140117", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "45231", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140117", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS 3000 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250826", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20140117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "86", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Death", "Fistula", "Myocardial Infarction", "Nausea", "Vomiting", "Blood Loss", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20131219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3582442", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140521", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "4035274", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC-ASSISTED LEFT PARTIAL NEPHRECTOMY FOR LEFT RENAL MASS ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE (OP) REPORT AND ALLEGATIONS OF PATIENT COMPLICATIONS. THE PATIENT ALLEGEDLY HAD TO UNDERGO ABDOMINAL EXPLORATION, LEFT COLECTOMY AND DIVERTING LOOP ILEOSTOMY ON (B)(6) 2011, APPROXIMATELY ONE MONTH AFTER HIS ROBOTIC PARTIAL NEPHRECTOMY TO REPAIR PERFORATED LEFT COLON WITH ABSCESS. PRIOR TO THE SECOND SURGERY, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2011 WITH COMPLAINTS OF ABDOMINAL PAIN ASSOCIATED WITH NAUSEA AND VOMITING. AT THE TIME, HE WAS FOUND TO HAVE PERINEPHRIC ABSCESS WITH POSSIBLE PERFORATION OF THE DESCENDING COLON. FURTHER EVALUATION REVEALED A WIDE BORE FISTULA FROM THE COLON INTO THE ABSCESS CAVITY. THE PATIENT DIED ON (B)(6) 2012 DUE TO ACUTE MYOCARDIAL INFARCTION. PER THE OP REPORT OF (B)(6) 2011, THE PATIENT'S LEFT RENAL MASS WAS FOUND INCIDENTALLY. THE MASS MEASURED 4 CM, LOCATED ON THE POSTEROLATERAL ASPECT OF THE UPPER POLE OF THE KIDNEY. PER THE OP REPORT, ALTERNATIVES, RISKS, AND BENEFITS WERE DISCUSSED WITH THE PATIENT AND INFORMED CONSENT WAS OBTAINED FOR THE ABOVE PROCEDURE. THE OP REPORTS STATES, THERE WERE SIGNIFICANT ADHESIONS AROUND THE SPLENIC FLEXURE AND THESE TOOK SOME TIME TO MOBILIZE. REPORT STATES THAT THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO COMPLICATIONS AND ESTIMATED BLOOD LOSS OF 450 ML. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. ANESTHESIA RECORD START TIME 0732, STOP TIME 1305. ON (B)(6) 2011, PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN ASSOCIATED WITH NAUSEA AND VOMITING. HE WAS NOTED TO HAVE A PERINEPHRIC ABSCESS WITH POSSIBLE PERFORATION OF THE DESCENDING COLON. PATIENT HAD FURTHER EVALUATION BY INTERVENTIONAL RADIOLOGY (IR) AND IT WAS NOTED THAT HE HAD A WIDE BORE FISTULAR FROM THE COLON INTO THE ABSCESS CAVITY WHICH WAS NOT ADEQUATELY DRAINED BY THE PERCUTANEOUS DRAIN. AT THIS POINT, THE RISKS, BENEFITS, AND ALTERNATIVES OF PERFORMING AN ABDOMINAL EXPLORATION WITH POSSIBLE LEFT COLECTOMY AND DIVERTING ILEOSTOMY WERE ALL EXPLAINED TO THE PATIENT IN GREAT DETAIL INCLUDING BUT NOT LIMITED TO INFECTION, BLEEDING, INJURY TO SURROUNDING VISCERA SUCH AS SPLEEN, SMALL BOWEL, URETER, ANASTOMOTIC LEAK, AND SYSTEMIC COMPLICATIONS SUCH AS PE, PNEUMONIA, DVT AND DEATH. THE PATIENT VOICED UNDERSTANDING AND ALL HIS QUESTIONS WERE ANSWERED APPROPRIATELY. IT IS UNCLEAR REGARDING THE DATE OF THE ABOVE AND TO WHAT SPECIFIC SURGERY THE ABOVE INFORMED CONSENT PERTAINS. THERE ARE NO RECORDS PROVIDED FOR THE PATIENT CONCERNING (B)(6) 2011, HOWEVER, THE PATIENT DID UNDERGO AN EXPLORATORY LAPAROTOMY ON (B)(6) 2011 PER AN ANESTHESIA RECORD PROVIDED . ON (B)(6) 2011, PATIENT UNDERWENT EXPLORATORY LAPAROTOMY FOR A COLON PERFORATION. THERE IS NO OP REPORT FOR THIS SURGERY. ON (B)(6) 2011, PATIENT UNDERWENT ABDOMINAL EXPLORATION, LEFT COLECTOMY AND DIVERTING LOOP ILEOSTOMY FOR PERFORATED LEFT COLON WITH ABSCESS. PER THE OP REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL. ESTIMATED BLOOD LOSS OF 100 ML. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11814958", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) WAS PROVIDED WITH THE PATIENT'S DEATH CERTIFICATE. THE CAUSE OF DEATH AS INDICATED IN THE DEATH CERTIFICATE IS ACUTE MYOCARDIAL INFARCTION ON (B)(6) 2012 AT 4:00PM. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER." }, { "mdr_text_key": "11555194", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, 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. 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S OPERATIVE REPORTS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY DIED ON (B)(6) 2012. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/29/2014" } ] }