{ "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": "2955842-2013-05407", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131122", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120423", "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": "20131125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "608871", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131122", "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", "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": "20250814", "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": "20131122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Anemia", "Arrhythmia", "Death", "Hemorrhage/Blood Loss/Bleeding", "Thrombosis", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20131104", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3484876", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140527", "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": "20712261", "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 THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. 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; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND COULD NOT BE RESUSCITATED. NO FURTHER INFORMATION WAS PROVIDED. ISI ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT GROUP FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "20898170", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT'S CAUSE OF DEATH IS ALSO UNKNOWN. THE MEDICAL RECORDS DO 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. 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 EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND THEN PASSED AWAY ON (B)(6) 2012." }, { "mdr_text_key": "19012047", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) IDENTIFIED THIS MDR IS A DUPLICATE REPORT OF PATIENT IDENTIFIER = (B)(4), MFR REPORT 2955842-2013-04055. WHEN THE INITIAL MDR FOR THIS REPORT WAS SUBMITTED ON (B)(4) 2013, IT WAS NOT KNOWN THAT BOTH MDR'S INVOLVED THE SAME PATIENT AND EVENT. THIS MDR IS BEING RETRACTED AS A DUPLICATE MDR OF PATIENT IDENTIFIER = (B)(4), MFR REPORT 2955842-2013-04055." } ], "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": "06/04/2014" } ] }