{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2026-15092", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260309", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260105", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260309", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240426", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "609561", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260309", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-50", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/31/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "Y", "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": "20260309", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "42 YR", "patient_sex": "Female", "patient_weight": "68 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Urinary Tract Infection", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260422", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24546143", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260209", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "395000861", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE." }, { "mdr_text_key": "395000862", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BENIGN HYSTERECTOMY WITH URETEROPLASTY SURGICAL PROCEDURE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT A KNOWN MYOMA WAS ENCASING THE URETER, REQUIRING A URETERAL REIMPLANTATION. DURING THIS REIMPLANTATION, THE URETER WAS DAMAGED. THE LIKELY REASON FOR THE DAMAGE WAS STRETCHING OR TRACTION OF THE URETER; THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH THIS EVENT. DESCRIPTION OF THE REPAIR WAS NOT PROVIDED. THERE WAS A PROCEDURE DELAY OF APPROXIMATELY 90 MINUTES AND THE PROCEDURE PROCEEDED WITHOUT FURTHER REPORTED DIFFICULTIES. THE EVENT WAS DEEMED RESOLVED WITH SEQUELAE FOUR DAYS LATER. DISCHARGE OCCURRED ON AN UNSPECIFIED DATE. THE STUDY INVESTIGATOR REPORTED THE EVENT OF URETERAL INJURY AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), AN OLSO CLASSIFICATION GRADE II, HAVING A CAUSAL RELATIONSHIP TO THE PATIENT'S UNDERLYING DISEASE STATUS, BUT NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE INVESTIGATIONAL DEVICE AND NOT RELATED TO A THIRD-PARTY DEVICE. THIRTY-ONE DAYS AFTER THE INDEX PROCEDURE, A PERSISTENT INFECTION RELATED TO THE URETERAL INJURY WAS REPORTED. AN UNSPECIFIED ORAL MEDICATION WAS ADMINISTERED BUT WAS UNSUCCESSFUL IN TREATMENT. THE INFECTION CONTINUED, REQUIRING RE-HOSPITALIZATION AND IS NOW BEING TREATED WITH MEROPENEM. THIS EVENT IS REPORTED AS ONGOING. THE STUDY INVESTIGATOR REPORTED THE INFECTION AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE. THE PATIENT'S PRIOR HEALTH CONDITION (URETERAL LESION) MAY BE RELEVANT TO THIS EVENT." }, { "mdr_text_key": "399233487", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: THE REPAIR IS REPORTED AS A RIGHT URETEROLYSIS, RESECTION OF ADENOMYOSIS FROM THE RIGHT PELVIC WALL WITH URETERAL REIMPLANTATION (PSOAS-HITCH), AND PLACEMENT OF A RIGHT-SIDED DJ STENT. THERE WERE NO DEVICE DEFICIENCIES DURING THE PROCEDURE AND NO POST-OPERATIVE COMPLICATIONS PRIOR TO DISCHARGE. ADDED TO ANNEX B: B15. ADDITIONAL PATIENT DEMOGRAPHIC INFORMATION: BODY MASS INDEX (BMI) 24.4 KG/M2 WITH A HEIGHT OF 167CM." }, { "mdr_text_key": "399233488", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/22/2026" } ] }