{ "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": "2955842-2024-12708", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240322", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240203", "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": "KS", "manufacturer_contact_area_code": "408", "date_added": "20240322", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2555036", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240322", "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", "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": "", "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": "20250819", "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": "20240322", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "47 YR", "patient_sex": "Female", "patient_weight": "59 KG", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "Bacterial Infection", "Fever", "Post Operative Wound Infection", "Bacterial Infection", "Fever", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20240223", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18957979", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240223", "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": "338309254", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POSTOPERATIVE COMPLICATION CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION." }, { "mdr_text_key": "338309255", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER DA VINCI-ASSISTED NIPPLE AREOLAR SKIN SPARING MASTECTOMY, SENTINEL LYMPH NODE BIOPSY, AND LEFT BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP PROCEDURES, THE PATIENT PRESENTED WITH SYMPTOMS OF INFECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO COMPLICATIONS ON POSTOPERATIVE DAY 6. ON POSTOPERATIVE DAY 9, THE PATIENT PRESENTED WITH A FEVER OF 38 DEGREES CELSIUS OR HIGHER, SWELLING, HEAT, AND REDNESS IN THE LEFT BREAST, AND AN INCREASE IN THE AMOUNT OF DRAINAGE BY 3 TIMES WITH THE JACKSON-PRATT (JP) DRAIN. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED AFTER BLOOD, DRAINAGE FLUID, AND URINE CULTURES WERE PERFORMED IN THE EMERGENCY ROOM (ER) UNDER SUSPICION OF A POSTOPERATIVE INFECTION; MODERATE STAPHYLOCOCCUS AUREUS BACTERIA WERE FOUND IN THE DRAINAGE FLUID, AND NO BACTERIA WERE IDENTIFIED IN THE BLOOD OR URINE. THE INFECTION WAS CONFIRMED VIA A CHEST COMPUTED TOMOGRAPHY (CT), AND THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A WOUND INFECTION IN THE LEFT BREAST. IN ADDITION TO IV ANTIBIOTICS, THE PATIENT ALSO UNDERWENT A HEMATOMA EVACUATION SURGERY AT THIS TIME; THE HEMATOMA WAS LOCATED BELOW THE NIPPLE OF THE LEFT BREAST. ON POSTOPERATIVE DAY 17, THE PATIENT WAS DISCHARGED WITH A HEMOVAC DRAIN INSERTED INTO THE LEFT BREAST SURGICAL SITE. LATER, ON POSTOPERATIVE DAY 26, THE OP SITE DRAIN WAS REMOVED AT AN OUTPATIENT FOLLOW-UP VISIT. CURRENTLY, THE PATIENT IS NOT EXPERIENCING ANY SPECIFIC ISSUES, AND THEY ARE UNDERGOING CHEMOTHERAPY TO TREAT INVASIVE DUCTAL CARCINOMA IN SITU IN THE LEFT BREAST, WHICH WAS DIAGNOSED ON THE DAY PRIOR TO THE DA VINCI-ASSISTED PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY OTHER POSTOPERATIVE COMPLICATIONS. THERE WERE NO INTRAOPERATIVE ISSUES OR A MALFUNCTION OF A DA VINCI DEVICE DURING THE INITIAL PROCEDURE. THE SURGEON DOES NOT BELIEVE THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE INFECTION. PER THE CUSTOMER, SURGICAL SITE INFECTIONS CAN HAVE VARIOUS CAUSES, INCLUDING A COMPROMISED IMMUNE SYSTEM, UNDERLYING PATIENT CONDITIONS, AND INTERNAL AND EXTERNAL ENVIRONMENTAL FACTORS. FOR THIS EVENT, THE CAUSE OF THE INFECTION WAS NOT SPECIFIED BY THE CUSTOMER. OTHER SURGEONS AT THE SITE HAVE ENCOUNTERED SIMILAR POSTOPERATIVE INFECTIONS; HOWEVER, THEY HAVE NOT BEEN LIMITED STRICTLY TO DA VINCI-ASSISTED SURGICAL PROCEDURES, AS HEMATOMAS AND/OR INFECTIONS CAN OCCUR IN ANY SURGERY. THE SITE'S INSTRUMENT CLEANING OR STERILIZATION METHODS HAVE NOT CHANGED RECENTLY." } ], "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": "" } ] }