{ "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": "2955842-2023-20389", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20231118", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231118", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "879658", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231118", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "R", "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": "20250727", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20231118", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hernia", "Hernia" ] } ], "distributor_city": "", "date_report": "20231018", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18166564", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231018", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "328480967", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ACCORDING TO A NEWSPAPER ARTICLE, THERE WAS A DA VINCI-ASSISTED COMPONENT SEPARATION SURGERY THAT HAD POST-OPERATIVE COMPLICATION WHICH REQUIRED AN ADDITIONAL SURGERY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A \"MICKEY MOUSE HERNIA\", WHERE THE PATIENT'S INTESTINES WERE BULGING OUT OF HER SIDES. THE SURGEON THAT PERFORMED THE REPAIR BELIEVED THE PROCEDURE WAS DONE INCORRECTLY AND THAT THAT THE ORIGINAL SURGEON HAD CUT INTO THE WRONG MUSCLE PLANE. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN ANY OF THE PROCEDURES IN THE ARTICLE." }, { "mdr_text_key": "328480968", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OR REPORT THAT A DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED POST-OPERATIVE COMPLICATION. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE HOSPITAL NAME, PROCEDURE DATE OR THE SYSTEM THAT WAS USED AND THUS A LOG REVIEW INVESTIGATION CANNOT PERFORMED. THIS MEDWATCH REPORT (PATIENT IDENTIFIER (B)(6) ) IS SUBMITTED FOR AN OPERATIVE COMPLICATION. SEPARATE MEDWATCH REPORTS (PATIENT IDENTIFIER (B)(6) ) ARE SUBMITTED FOR OTHER OPERATIVE COMPLICATIONS MENTIONED IN THE SAME ARTICLE. SECTION E INITIAL REPORTER: THIS SECTION DOCUMENTS THE REPORTER NAME AS AN AUTHOR OF THE NEWSPAPER ARTICLE. THE SITE/HOSPITAL WHERE THE PROCEDURE WAS PERFORMED AND ASSOCIATED INFORMATION IS UNKNOWN. SOURCE OF ARTICLE: HTTPS://WWW.NYTIMES.COM/2023/10/30/HEALTH/HERNIA-SURGERY-COMPONENT-SEPARATION.HTML." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }