{ "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": "2955842-2023-12187", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230425", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20181129", "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", "Literature", "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": "20230425", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "684609", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230425", "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": "20250827", "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": "20230425", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "37 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Seroma", "Burn(s)", "Seroma" ] } ], "distributor_city": "", "date_report": "20230328", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16812051", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230328", "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": "313987364", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE MENTIONED BURN AND POST-OPERATIVE REDNESS AND HEATING SENSATION CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND 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. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH DOES NOT REVEAL ANY RELATED OR DUPLICATE RECORDS . A SYSTEM LOG CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME AS THERE WAS INSUFFICIENT INFORMATION. A REVIEW OF THE IMAGE ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOP ENGINEERS AND FOUND THAT INTHE ATTACHED IMAGE(B) SKIN LESIONS ARE OBSERVED. IT IT SEEMS THAT A THE ROBOTIC CANNULA WAS INSERTED INTO A GEL POINT THAT WAS ATTACHED TO THE WOUND PROTECTOR. THE DA VINCI SP CANNULA IS ONLY VALIDATED FOR USE WITH THE FOLLOWING ACCESSORIES: ENTRY GUIDE KIT C6.6, 25MMX100MM (INCLUDES ENTRYGUIDE CANNULA INSERT AND ENTRY GUIDE CANNULA SEAL ) AND SP OBTURATOR, CIRCULATOR, 25MMX100MM. HENCE, THE ROBOTIC CANNULA IS NOT COMPATIBLE WITH GEL POINT ACCESSORIES AND IT IS POSSIBLE THAT THE BURN WAS DUE TO STRAY CAUTERY FROM DOUBLE CANNULATION (ROBOTIC CANNULA + GEL POINT). THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE, AND IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON 29-NOV-2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. POST-OPERATIVE DAY 55, THE PATIENT ALSO EXPERIENCED REDNESS AND HEATING SENSATION OF THE RIGHT BREAST, WHICH ANTIBIOTICS AND CONSERVATIVE TREATMENT WAS GIVEN AS WELL AS DRAINAGE WAS APPLIED. THE SYMPTOMS WERE SUBSIDED AFTER 1 DAY, WITHOUT ANY SURGICAL INTERVENTION NEEDED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "313987365", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK, H.S., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON (B)(6) 2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. THERE WERE NO OTHER IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 15 AND DRAIN WAS REMOVED ON DAY 24. PATIENT RE-VISITED THE CLINIC ON DAY 55 BECAUSE OF REDNESS AND HEATING SENSATION OF THE RIGHT BREAST. ANTIBIOTICS AND CONSERVATIVE TREATMENT INCLUDING DRESSING AND RE-INSERTION OF THE DRAIN WERE APPLIED. HER SYMPTOMS SUBSIDED AFTER 1 DAY OF TREATMENT AND NO MAJOR SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO MENTION OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. FENESTRATED BIPOLAR FOCEPS (FBF) INSTRUMENT, MARLAND FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) WERE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(USM) 1, 2 AND 3, RESPECTIVELY, WITH NO MALFUNCTIONS REPORTED. INTUITIVE SURGICAL, INC, (ISI) MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR, BUT THE AUTHOR DID NOT SHARE ANY ADDITIONAL INFORMATION DUE TO PATIENT PRIVACY." } ], "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": "" } ] }