{ "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": "2955842-2024-19273", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240913", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20231122", "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", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20240913", "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": "1207946", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240913", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "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": "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": "US", "date_changed": "20250821", "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": "20240913", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "54 YR", "patient_sex": "Male", "patient_weight": "59 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Purulent Discharge", "Post Operative Wound Infection", "Purulent Discharge", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20240820", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20212676", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240820", "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": "351724799", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS WERE NOT AVAILABLE." }, { "mdr_text_key": "351724800", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. APPROXIMATELY NINE MONTHS LATER, THE PATIENT UNDERWENT A SURGERY FOR INTESTINAL ADHESIONS. ON POST-OPERATIVE DAY THREE, A SMALL AMOUNT OF RED AND WHITE PUS DISCHARGED FROM THE UMBILICAL WOUND WHEN CLEANING WITH SALINE. THE DRESSING WAS SWITCHED TO A WET SALINE DRESSING. ON POST-OPERATIVE DAY SEVEN, THE PATIENT UNDERWENT STOMA SURGERY, WITH A STOMA PLACED IN THE LOWER RIGHT ABDOMEN, A NASOGASTRIC TUBE FOR CONTINUOUS DRAINAGE, AND A RECTAL TUBE FOR CONTINUOUS DRAINAGE OF MODERATE AMOUNTS OF DARK GREENISH-BROWN LIQUID STOOL. ON POST-OPERATIVE DAY EIGHT, A SMALL AMOUNT OF BROWNISH EXUDATE WAS FOUND FROM THE UMBILICAL WOUND. ON THE FOLLOWING DAY, A SAMPLE OF THE BROWNISH EXUDATE FROM THE UMBILICAL WOUND WAS TAKEN FOR CULTURE, AND ANTIBIOTICS WERE ADMINISTERED. ON POST-OPERATIVE DAY 10, THE RECTAL AND NASOGASTRIC TUBES REMOVED. THE ABDOMINAL DISTENSION IMPROVED SIGNIFICANTLY, AND THE DISCOMFORT WAS REDUCED. THE CLEAR LIQUID DIET WAS WELL-TOLERATED. ON POST-OPERATIVE DAY 11, THE UMBILICAL WOUND HAD BROWNISH EXUDATE. THE SUTURES WERE REMOVED, AND POVIDONE-IODINE WAS USED TO PACK THE WOUND AND DRAIN THE PUS. ON POST-OPERATIVE DAY 12, A NORMAL DIET WAS RESUMED. ON POST-OPERATIVE DAY 17, THE PATIENT HAD A GOOD APPETITE, NO VOMITING, THE STOMA OUTPUT WAS SMOOTH AND THERE WAS NO FEVER. THERE ARE NO OTHER DISCOMFORTS, AND THE EVENT HAS BEEN DOCUMENTED RESOLVED WITHOUT ANY FURTHER PUS DISCHARGE. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 25 WITH THE STOMA STILL IN PLACE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PHYSICIAN BELIEVED THE INFECTION WAS RELATED TO POST-OPERATIVE CARE/THE POST-OPERATIVE ENVIRONMENT. THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE AND THE PHYSICIAN DID NOT BELIEVE THAT A DA VINCI DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }