{ "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": "Injury", "report_number": "2955842-2013-02493", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130710", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101014", "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": "20130710", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "318959", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130710", "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": "IS3000 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20130710", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Tissue Damage", "Injury", "Disability", "Cognitive Changes" ] } ], "distributor_city": "", "date_report": "20130103", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3217393", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130103", "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": "17616995", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI BILATERAL SALPINGO OOPHORECTOMY AND HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED DAMAGE TO HER URETERS AND SUFFERED SEVERE AND PERMANENT INJURIES INCLUDING SEVERE INTERNAL INJURIES. IN ADDITION, THE LEGAL COMPLAINT ALLEGED THAT SHE SUSTAINED PAIN AND SUFFERING, DISABILITY, PHYSICAL IMPAIRMENT, MENTAL IMPAIRMENT, DISFIGUREMENT, MENTAL ANGUISH, INCONVENIENCE AND LOSS OF CAPACITY FOR THE ENJOYMENT OF LIFE, ALL OF WHICH ARE CONTINUING AND ARE PERMANENT IN NATURE. SHE HAS INCURRED MEDICAL AND RELATED EXPENSES AND WILL CONTINUE TO INCUR SUCH EXPENSES IN THE FUTURE. SHE HAS LOST WAGES IN THE PAST AND HAS SUFFERED A LOSS OF EARNING CAPACITY WHICH IS CONTINUING AND PERMANENT IN NATURE." }, { "mdr_text_key": "17673051", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE RISK MANAGER INDICATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER MENTIONED THAT THE PATIENT HAD SUBSEQUENT ADMISSIONS AND UNSPECIFIED SURGICAL PROCEDURES PERFORMED AT ONE OR MORE DIFFERENT HOSPITALS. HOWEVER, SHE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT OR THE PATIENT'S SUBSEQUENT ADMISSIONS TO THE OTHER HOSPITAL(S). ISI HAS REVIEWED THE OPERATIVE REPORT OF THE PATIENT AND THERE WAS NO COMPLAINT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. NO INTRA-OPERATIVE COMPLICATIONS RELATED TO THE PATIENT'S URETERS WERE REPORTED. THE OPERATIVE REPORT INDICATED THAT AT THE END OF THE SURGICAL PROCEDURE, IRRIGATION WAS CARRIED OUT. ALL THE COUNTS WERE CORRECT. HEMOSTASIS WAS ADEQUATE. ALL THE ROBOTIC INSTRUMENTS WERE REMOVED UNDER DIRECT VISUALIZATION. ALL TROCARS WERE REMOVED UNDER DIRECT VISUALIZATION. ALSO, AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ISI HAS ALSO REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013, AND NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING 3 DA VINCI SURGICAL PROCEDURES PERFORMED THAT DAY. IN ADDITION, ALL INSTRUMENTS USED DURING THE SURGICAL PROCEDURES THAT DAY WERE FOUND TO HAVE BEEN REPROCESSED AND USED AGAIN IN SUBSEQUENT SURGERIES WITH NO COMPLAINTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE UNDERWENT A DA VINCI SI SURGICAL PROCEDURE AND SUSTAINED DAMAGE TO HER URETERS. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "" } ] }