{ "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": "I", "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": "2955842-2021-11265", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211011", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20211011", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1508879", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211011", "brand_name": "DA VINCI", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "UNKNOWN", "catalog_number": "N/A", "lot_number": "N/A", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20211011", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Insufficient Information", "Incontinence", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210915", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12603207", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210915", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "275882124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI WAS UNABLE TO CONDUCT SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF INFORMATION ON FILE AT THIS TIME. THERE IS NO SPECIFIC ALLEGATION TO INVESTIGATE. UNABLE TO CONDUCT SITE HISTORY COMPLAINT REVIEW AS SITE INFORMATION IS UNKNOWN. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THERE IS INSUFFICIENT INFORMATION PROVIDED TO SUGGEST THAT AN ISI PRODUCT MALFUNCTIONED, NOR IS THERE ANY CONFIRMED SITE, PROCEDURE, DA VINCI SYSTEM, OR DA VINCI INSTRUMENTATION INFORMATION. WHILE THERE IS NO SPECIFIC ALLEGATION TO INVESTIGATE AT THIS TIME, THERE WAS A REPORT THAT AFTER A DA VINCI PROCEDURE FOR UTERUS REMOVAL, A PATIENT EXPERIENCED PHYSICAL CHANGES TO HER STOOL, HER SLEEP PATTERNS, AND HER URINARY CONTINENCE. ADDITIONAL DETAILS WERE REQUESTED BY THE ISI CS REPRESENTATIVE BUT WERE NOT PROVIDED BY THE INITIAL REPORTER. ISI HAS REACHED OUT TO THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ADDITIONAL EVENT DETAILS AND THE ROOT CAUSE OF THE REPORTED EVENT ARE UNKNOWN." }, { "mdr_text_key": "275882125", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SERVICE (CS) REPRESENTATIVE RECEIVED AN INCOMING CALL AND IT WAS INITIALLY REPORTED THAT AN UNSPECIFIED PATIENT HAD A DA VINCI SURGERY FOR UTERUS REMOVAL AND THAT SHE HAD PHYSICAL CHANGES AFTERWARDS TO HER STOOL, HER SLEEP PATTERNS, AND HER URINARY CONTINENCE. WHEN ADDITIONAL DETAILS WERE REQUESTED, THEY WERE REFUSED BY THE INITIAL REPORTER. NO HOSPITAL, SURGEON, PROCEDURE DATE/DATE RANGE, OR PATIENT INFORMATION WAS ABLE TO BE OBTAINED. ISI HAS REACHED OUT TO THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "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": "" } ] }