{ "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": "2955842-2014-01030", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140220", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100617", "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": "20140221", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "107580", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140220", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": "20250724", "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": "20140220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Ischemia", "Laceration(s)", "Nausea", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20140130", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3638256", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140130", "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": "15323531", "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 RADICAL CYSTECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION INCLUDING EXTERNAL ILIAC, INTERNAL ILIAC AND OBTURATOR NODES, AND ILEAL CONDUIT CREATION FOR BACILLUS CALMETTE-GUERIN (BCG) REFRACTORY INVASIVE BLADDER CANCER ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGES, PT HAD BLADDER REMOVED AND THEY BELIEVED THE SURGERY WENT WELL. PT BECAME ILL ON THE EVENING OF THE SURGERY AND WAS MOVED TO ICU. PT'S COLON WAS NICKED AND PT DIED 6 DAYS LATER. ISI WAS PROVIDED WITH THE OPERATIVE (OP) REPORT OF THE DA VINCI RADICAL CYSTECTOMY PROCEDURE. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. AFTER COMPLETION OF THE ROBOTIC PORTION OF THE SURGERY, THE ROBOT WAS UNDOCKED. ISI WAS ALSO PROVIDED THE OP REPORT FOR THE SURGICAL PROCEDURE THAT IMMEDIATELY FOLLOWED THE ROBOTIC PORTION OF THE SURGERY. THE OP REPORT WAS FOR AN ILEAL CONDUIT URINARY DIVERSION AND URETEROILEAL REIMPLANTATION FOR BLADDER CANCER, MUSCLE-INVASIVE STATUS POST CYSTECTOMY REQUIRING URINARY DIVERSION. ACCORDING TO THE OP REPORT, BLOOD LOSS WAS APPROXIMATELY 300 TO 400 ML AND NO COMPLICATIONS WERE NOTED. PER THE DISCHARGE SUMMARY, ON POSTOPERATIVE DAY 3, THE PATIENT DEVELOPED NAUSEA AND AN NG TUBE WAS PLACED. HE HAD HIGH NG OUTPUTS FOR 2 DAYS AND HAD GRADUALLY DECREASING URINE OUTPUT. ON POSTOP DAY 5, HE WAS ADMITTED TO THE INTENSIVE CARE UNIT. CT SCAN AT THAT TIME WAS UNREMARKABLE AND DID NOT SHOW EVIDENCE OF A BOWEL OBSTRUCTION, BOWEL LEAK, ABSCESS, OR URINE LEAK. THE PATIENT WAS RE-EXPLORED ON POSTOP DAY 7 BY GENERAL SURGERY AND WAS FOUND TO HAVE AN ISCHEMIC BOWEL. SPECIFICALLY, HE APPEARED TO HAVE SEVERE ISCHEMIA OF HIS COLON, PRESUMABLY FROM SOME EMBOLIC PHENOMENA. HE UNDERWENT A SUBTOTAL COLECTOMY AND LATER THAT AFTERNOON HE WAS FOUND TO HAVE A DILATED PUPIL, WORRISOME FOR AN EMBOLIC STROKE. AS HE WAS BEING TAKEN TO THE CT SCAN, HE DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND COULD NOT BE RESUSCITATED. THE PATIENT EXPIRED. ON (B)(4) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE. THE RISK MANAGER REVIEWED THE PATIENT'S MEDICAL RECORDS AND OP REPORTS. SHE DID NOT FIND ANY INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI RADICAL CYSTECTOMY PROCEDURE. SHE ALSO DID NOT FIND ANY INDICATION THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED OR THAT THE PATIENT'S BOWEL WAS NICKED AS ALLEGED ON THE LEGAL DOCUMENT. THE RISK MANAGER STATED THAT AN AUTOPSY WAS NOT PERFORMED. SHE DID NOT KNOW THE PATIENT'S CAUSE OF DEATH." }, { "mdr_text_key": "22346864", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "." }, { "mdr_text_key": "15787535", "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 OP REPORT FOR THE ROBOTIC SURGERY 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 REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. 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 MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE IS UNKNOWN. ALSO, THERE IS NO INDICATION THAT THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE." } ], "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": "01/13/2015" } ] }