{ "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": "2955842-2023-17988", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230824", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230611", "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": "20230824", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1639087", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230824", "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": "20250815", "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": "20230824", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "46 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Seroma", "Post Operative Wound Infection", "Unspecified Tissue Injury", "Seroma", "Post Operative Wound Infection", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230731", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17619097", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230731", "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": "321919700", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENT CANNOT BE DETERMINED. THIS MEDWATCH REPORT (PATIENT IDENTIFIER #(B)(6)) IS SUBMITTED FOR THE OPERATIVE COMPLICATIONS OCCURRED IN THE SP GROUP AND THE MEDWATCH REPORT (PATIENT IDENTIFIER #(B)(6)) IS SUBMITTED FOR THE OPERATIVE COMPLICATIONS OCCURRED IN THE MULTIPORT GROUP MENTIONED IN THE SAME ARTICLE. ARTICLE CITATION: CHOI, Y.J., SANG, N.T., JO, HS. ET AL. A SINGLE-CENTER EXPERIENCE OF OVER 300 CASES OF SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY COMPARING THE DA VINCI SP WITH THE SI/XI SYSTEMS. SCI REP 13, 9482 (2023). HTTPS://DOI.ORG/10.1038/S41598-023-36055-X. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FOR SECTION A2 : MAJORITY OF THE PATIENTS WERE FEMALE, WHILE 94 PATIENTS WERE MALE (43%). THE TOTAL MEAN AGE WAS 46.21 ± 11.40 YEARS AND THE MEAN BMI WAS25.95 ± 22.36 KG/M2. ALL THE PATIENTS WERE ASA I OR II. 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": "321919701", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿A SINGLE-CENTER EXPERIENCE OF OVER 300 CASES OF SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY COMPARING THE DA VINCI SP WITH THE SI/XI SYSTEMS¿, THE FOLLOWING EVENTS WERE REPORTED. A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY BETWEEN (B)(6) 2014 AND (B)(6) 2021 AT A SINGLE CENTER WERE INCLUDED IN THE STUDY. IN TOTAL, 334 PATIENTS UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMIES, WITH 118 PATIENTS USING SI/XI SYSTEM AND 216 PATIENTS USING SINGLE PORT (SP). OF THE 216 PATIENTS THAT UNDERWENT SP SURGERIES, TWO PATIENTS IN THE SP GROUP CONVERTED TO MULTIPORT LAPAROSCOPIC SURGERIES. THE CONVERSION WAS DUE TO ONE OF THE PATIENTS HAD ACUTE CHOLECYSTITIS AND THE OTHER HAD SEVERE ADHESIONS FROM PREVIOUS UPPER ABDOMINAL SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, SUCH AS MASSIVE BLEEDING OR BILE DUCT INJURIES. SEVEN PATIENTS WERE OBSERVED WITH ACUTE INFLAMMATION INTRA-OPERATIVELY. THE ESTIMATED BLOOD LOSS FOR ALL PATIENTS WAS < 50ML, EXCEPT FOR THE CASES THAT REQUIRED CONVERSION TO LAPAROSCOPIC SURGERIES. THE RATE OF POST-OPERATIVE COMPLICATIONS IN SP SURGERIES WAS 10.6%. THE MOST COMMON COMPLICATIONS WERE WOUND PROBLEMS INCLUDING SEROMA (3.2%) AND INFECTION (5.1%). THE INCISION HERNIA RATE WAS 1.4% IN THE SP GROUP. THERE WAS ONE CASE OF FLUID COLLECTION IN THE ABDOMINAL CAVITY REQUIRED PERCUTANEOUS DRAINAGE. NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES WERE MENTIONED IN THE ARTICLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." } ], "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": "" } ] }