{ "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": "2955842-2022-11772", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220523", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20200721", "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", "Foreign", "Study" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "408", "date_added": "20220523", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "527013", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220523", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20220523", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Sepsis", "Peritonitis", "Fever", "Sepsis", "Peritonitis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14467667", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200721", "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": "292744190", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 21-JUL- 2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SURGICAL ENDOSCOPY ARTICLE TITLED, ¿ROBOTIC TREATMENT FOR URINARY TRACT ENDOMETRIOSIS: PRELIMINARY RESULTS AND SURGICAL DETAILS IN A HIGH-VOLUME SINGLE-INSTITUTIONAL COHORT STUDY¿ (DIMAIDA, F., MARI,. A., MORESELLI, S., ET AL., 2020). THE AIM OF THE STUDY WAS TO PRESENT THE SURGICAL TECHNIQUES AND THE POSTOPERATIVE OUTCOMES IN WOMEN TREATED WITH ROBOTIC EXCISION FOR DEEP ENDOMETRIOSIS INVOLVING THE URINARY TRACT. THIS STUDY RETROSPECTIVELY REVIEWED THE PROSPECTIVELY RECORDED CLINICAL DATA OF WOMEN CONSECUTIVELY UNDERGOING MINIMALLY INVASIVE TREATMENT FOR COMPLEX ENDOMETRIOSIS INVOLVING URINARY TRACT IN OUR CENTER BETWEEN JANUARY 2012 AND JUNE 2018. A TOTAL OF 74 CONSECUTIVE PATIENTS WERE ENROLLED AND, OF WHICH, 46 WERE TREATED WITH ROBOTIC SURGERY WITH EITHER A DA VINCI SI OR XI DA VINCI SURGICAL SYSTEM. ALL THE PATIENTS RECEIVED A PREOPERATIVE MULTIDISCIPLINARY EVALUATION WITH THE GENERAL SURGEON, THE GYNECOLOGIST, AND THE UROLOGIST DUE TO THE FREQUENT CONCOMITANT INVOLVEMENT OF BOWEL AND GENITAL SYSTEM. PATIENTS UNDERGOING ROBOTIC SURGERY WERE TREATED WITH THE SI OR XI DA VINCI SURGICAL SYSTEM. WITHIN THE JOURNAL ARTICLE, THE FOLLOWING POST-OPERATIVE FEATURES INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED OF THE 46 PATIENTS TREATED WITH EITHER THE DA VINCI SI OR XI SURGICAL SYSTEM: FIVE POSTOPERATIVE COMPLICATIONS THREE SURGICAL COMPLICATIONS: TWO INSTANCES OF BLEEDING REQUIRING TRANSFUSIONS AND ONE INSTANCE OF PERITONITIS AND SEPSIS REQUIRING SURGICAL REINTERVENTION TWO MEDICAL COMPLICATIONS: ONE INSTANCE OF PROLONGED FEVER AND ONE INSTANCE OF A RESPIRATORY COMPLICATION. AN AVERAGE LENGTH OF STAY OF 4 DAYS, TWO INSTANCES OF POSTOPERATIVE PAIN SYMPTOMS, FOUR INSTANCES OF ENDOMETRIOSIS RECURRENCE AT THE URINARY TRACT. THE MEAN AGE OF THE PATIENTS TREATED WITH EITHER THE DA VINCI SI OR XI SURGICAL SYSTEM WAS 34.7 YEARS OLD. THEIR BMI IS RANGED FROM 21.9-28.1. THE REPORTED CONCLUSION OF THE ARTICLE WAS AS FOLLOWS: ROBOTIC EXCISION OF UROLOGICAL ENDOMETRIOSIS REPRESENTS A SAFE AND EFFECTIVE TREATMENT OPTION, SINCE A LIMITED RATE OF SURGICAL COMPLICATIONS WAS RECORDED EVEN IN CASES OF MULTI-ORGAN DISEASE. THERE IS NO INDICATION OR ALLEGATION THAT A DA VINCI PRODUCT MALFUNCTIONED OR CAUSED/CONTRIBUTED TO THE COMPLICATIONS. ADDITIONALLY, IT WAS NOTED THAT ZERO OF THE CASES WERE CONVERTED TO LAPAROTOMY. ISI FOLLOWED-UP WITH THE ARTICLE CORRESPONDENT AND RECEIVED A RESPONSE FROM ANOTHER PHYSICIAN AT THE INSTITUTION: ¿WE REPORTED THE FOLLOWING POSTOPERATIVE COMPLICATIONS: PERITONITIS AND SEPSIS REQUIRING SURGICAL REINTERVENTION, PROLONGED FEVER, RESPIRATORY COMPLICATION\" ADDITIONALLY, THE ARTICLE CORRESPONDENT INDICATED, \"ALL THE EVENTS LISTED ABOVE ARE POSSIBLE COMPLICATIONS AFTER SURGERY FOR ENDOMETRIOSIS. IN ALL CASES COMPLICATIONS WERE NOT RELATED TO MALFUNCTION OF DA VINCI SYSTEM.¿" }, { "mdr_text_key": "292744191", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION CURRENTLY MADE AVAILABLE, THERE IS NO INDICATION THAT AN ISI DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. THE ARTICLE CORRESPONDENT INDICATED THAT THE COMPLICATIONS NOTED ARE POSSIBLE COMPLICATIONS AFTER ENDOMETRIOSIS SURGERY AND WERE NOT RELATED TO A MALFUNCTION OF A DA VINCI SYSTEM. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THE SYSTEM LOGS CANNOT BE REVIEWED AS THERE IS INSUFFICIENT INFORMATION AVAILABLE AT THIS TIME TO PERFORM A REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITH THE ARTICLE TITLED, ¿ROBOTIC TREATMENT FOR URINARY TRACT ENDOMETRIOSIS: PRELIMINARY RESULTS AND SURGICAL DETAILS IN A HIGH-VOLUME SINGLE-INSTITUTIONAL COHORT STUDY,¿ SURGICAL AND POSTOPERATIVE COMPLICATIONS WERE REPORTED TO HAVE OCCURRED DURING OR FOLLOWING DA VINCI-ASSISTED SURGICAL PROCEDURES ANALYZED AS PART OF A STUDY. WHILE THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSE OF THE COMPLICATIONS IS UNKNOWN." } ], "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": "" } ] }