{ "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": "2955842-2021-11774", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211218", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20211004", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20211218", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1932640", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211218", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "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": "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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250820", "health_professional": "Y", "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": "20211218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation", "Pneumonia", "Perforation", "Pneumonia" ] } ], "distributor_city": "", "date_report": "20211122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13036309", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211122", "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": "285755409", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION OF A DA VINCI PRODUCT MALFUNCTION, SO NO PRODUCT IS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. A SITE HISTORY COMPLAINT REVIEW COULD NOT BE CONFIRMED DUE TO A LACK OF PRODUCT INFORMATION AND PROCEDURE DATES. NO IMAGE OR PROCEDURE VIDEOS WERE PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿HELLER MYOTOMY PERFORATION: ROBOTIC VISUALIZATION DECREASES PERFORATION RATE AND REVISIONAL SURGERY IS A PERFORATION RISK,¿ POSTOPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED. ONE PATIENT SHOWED A LEAK ON POSTOPERATIVE ESOPHAGOGRAM AND IT WAS DETERMINED THAT THE PATIENT HAD SUSTAINED A PERFORATION WHILE UNDERGOING REVISIONAL ROBOTIC SURGERY. THE PERFORATION CONTRIBUTED TO A PROLONGED HOSPITAL STAY. THE PATIENT WAS ADMINISTERED SUPPORTIVE MEASURES, ANTIBIOTICS, AND NUTRITION. AT THIS TIME, THE ROOT CAUSE OF THE ALLEGED COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "285755410", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿HELLER MYOTOMY PERFORATION: ROBOTIC VISUALIZATION DECREASES PERFORATION RATE AND REVISIONAL SURGERY IS A PERFORATION RISK¿ (ENGWALL-GILL, A. J., SOLEIMANI, T. ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: \"ONLY ONE PATIENT, WHO WAS IN THE ROBOTIC GROUP, SHOWED A LEAK ON POSTOPERATIVE ESOPHAGRAM. THIS DIRECTLY CONTRIBUTED TO HER PROLONGED POSTOPERATIVE STAY. THIS PATIENT HAD SUSTAINED A PERFORATION AT HER ORIGINAL LAPAROSCOPIC SURGERY AND THEN SUSTAINED PERFORATION AGAIN WHILE UNDERGOING REVISIONAL ROBOTIC SURGERY. IN THIS PARTICULAR CASE, THERE WAS MINIMAL LEAK OF CONTRAST INTO A CONTAINED PERFORATION, WHICH RESPONDED TO SUPPORTIVE MEASURES, ANTIBIOTICS, AND NUTRITION. SHE WAS HOSPITALIZED FOR A TOTAL OF 11 DAYS DUE TO AN EARLY POSTOPERATIVE COMPLICATION OF PNEUMONIA.\" ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "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": "" } ] }