{ "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": "Death", "report_number": "2955842-2026-04766", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260224", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250306", "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", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260224", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "487864", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260224", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "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": "N", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260430", "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": "20260224", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "58 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aspiration/Inhalation", "Cardiac Arrest", "Pneumonia" ] } ], "distributor_city": "", "date_report": "20260128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24430282", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260128", "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": "393806762", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SYSTEM LOGS REVIEW CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE IS INSUFFICIENT EVENT DATE INFORMATION. NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. A REVIEW OF THE REPORTED ADVERSE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT A PATIENT IN THIS INGUINAL HERNIA STUDY DIED AS A RESULT OF AN ASPIRATION EVENT AND CARDIAC ARREST. THERE IS NO ALLEGATION AGAINST ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. CITATION: TAGERMAN D, NESSEN M, LIMA DL, ET AL. ROBOTIC INGUINAL HERNIA REPAIR FOR THE NEW ROBOTIC SURGEON¿SAFETY AND EARLY OUTCOMES IN A LARGE ACADEMIC MEDICAL CENTER. J LAPAROENDOSC ADV SURG TECH. 2025;00(00). DOI:10.1089/LAP.2025.0051. SECTION A2: PATIENT AGE: REFLECTS THE STUDY MEAN YEARS OF 58. THE MAJORITY AGE RANGE WAS BETWEEM 43 AND 73 YRS. SECTION A3A- PATIENT GENDER IS SELECTED AS MALE. (88.2% OF THE PATIENTS ARE MALE). SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS IN THE ROBOTIC GROUP COHORT. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON BOTH DA VINCI XI AND SI SYSTEMS. THERE WAS NO DIFFERENTIATION PROVIDED REGARDING WHICH SYSTEM WAS USED PER PROCEDURE. SECTION E - THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT. SECTION H10: RELATED MANUFACTURER REPORT NUMBER 2955842-2026-04862 IS A RELATED REPORT FOR THE SERIOUS EVENTS REPORTED IN THE SAME ARTICLE." }, { "mdr_text_key": "393806763", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. ONE PATIENT DIED WITHIN 30 DAYS POST SURGERY DUE TO ASPIRATION PNEUMONIA LEADING TO CARDIAC ARREST. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL INC, (ISI) CONTACTED THE AUTHOR WHO REPORTED THAT THERE WERE NO ISSUES SEEN OR RECORDED WITH THE DA VINCI SYSTEM DURING THE STUDY. THE SYSTEM ITSELF DID NOT CONTRIBUTE TO THE DEATH IN THE STUDY WHICH WAS RELATED TO THE PATIENTS CO MORBIDITY AND NOT THE SURGERY ITSELF." } ], "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": "" } ] }