{ "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": "2955842-2023-11959", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230414", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230210", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20230414", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1087417", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230414", "brand_name": "DA VINCI SP", "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": "380601-45", "catalog_number": "380601", "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "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": "20230414", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "70 YR", "patient_sex": "Male", "patient_weight": "45 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Abdominal Pain", "Hematuria", "Ascites", "Abdominal Pain", "Hematuria", "Ascites" ] } ], "distributor_city": "", "date_report": "20230315", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16743309", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230315", "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": "313323846", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED SP EXTRAPERITONEAL PROSTATECTOMY ON (B)(6) 2023 AS PART OF THE CGMH URO SP CLINICAL STUDY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023 WITH ABDOMINAL DISCOMFORT AND SWELLING WITH NO URINE OUTPUT INTO HIS URINARY BAG. THE PHYSICIAN AT THE EMERGENCY ROOM OBSERVED THAT THE PATIENT HAD ABDOMINAL SWELLING, DISCOMFORT IN ABDOMINAL AND GENITAL AREA WITH THE PAIN ASSESSMENT 1 OUT OF 10, AND MILD HEMATURIA. CYSTOGRAPHY AND CT OF UROGRAPHY (CTU) INITIALLY CONFIRMED ASCITES. SUPRAPUBIC CYSTOSTOMY WAS PERFORMED AS TREATMENT. THE STUDY INVESTIGATOR ASSESSED THIS EVENT AS NOT RELATED TO DA-VINCI DEVICES, AND POSSIBLY RELATED TO THE PROCEDURE. INTUITIVE SURGICAL INC (ISI) OBTAINED ADDITIONAL INFORMATION AS THE FOLLOWING: THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR ANY OTHER POST-OPERATIVE COMPLICATIONS. THERE WERE NO ALLEGATIONS OF ANY MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. THE PATIENT WAS LATER FOUND WITH PERIVESICAL FLUID INSTEAD OF ASCITES VIA CT SCAN. A PIGTAIL DRAIN WAS PLACED. AFTER ADMISSION, CYSTOGRAPHY SHOWED MINIMAL LEAKAGE OF URINE FROM ANASTOMOSIS SITE. THEREFORE, THE PERIVESICAL FLUID WAS MORE LIKELY A LYMPHOCELE, AND RELATED TO PELVIC LYMPH NODE DISSECTION. THE URINE CATHETER (FOLEY) WAS REMOVED AS PLANNED WITH NORMAL FUNCTION. THE PIGTAIL DRAIN HAD MINIMAL DAILY DRAINAGE AMOUNT AFTER THE FIRST DRAINAGE, AND NOTED NOT INCREASING. THE PIGTAIL DRAIN WAS THEN REMOVED AT THE OUTPATIENT CLINIC AFTER THE PATIENT BEING DISCHARGED. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS, AND FULLY RECOVERED FROM THE REPORTED ADVERSE EVENT." }, { "mdr_text_key": "313323847", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION(S) CANNOT BE DETERMINED. THERE WAS NO REPORT OF A MALFUNCTION OF A DA VINCI PRODUCT, THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AS PART OF A CLINICAL STUDY, A PATIENT UNDERWENT A DA VINCI-ASSISTED SP EXTRAPERITONEAL PROSTATECTOMY AND PRESENTED TO THE ER ON POST-OPERATIVE DAY #5 WITH ABDOMINAL DISCOMFORT AND SWELLING WITH NO URINE OUTPUT INTO HIS URINARY BAG AND MILD HEMATURIA. THE PATIENT WAS LATER FOUND WITH PERIVESICAL FLUID INSTEAD OF ASCITES VIA CT SCAN AND PIGTAIL DRAIN WAS PLACED. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS, AND FULLY RECOVERED FROM THE REPORTED ADVERSE EVENT. THE STUDY INVESTIGATOR ASSESSED THIS EVENT AS NOT RELATED TO DA VINCI DEVICES, AND POSSIBLY RELATED TO THE PROCEDURE." } ], "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": "" } ] }