{ "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": "2955842-2023-17028", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230713", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20200911", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "20230713", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2260263", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230713", "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": "20250730", "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": "20230713", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Tissue Breakdown", "Fever", "Tissue Breakdown" ] } ], "distributor_city": "", "date_report": "20230615", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17317590", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230615", "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": "319119479", "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 OPERATIVE INCIDENT CANNOT BE DETERMINED. THIS MEDWATCH REPORT (PATIENT IDENTIFIER # (B)(6)) IS BEING SUBMITTED FOR THE OPERATIVE COMPLICATIONS ASSOCIATED WITH SINGLE PORT SYSTEMS AND MEDWATCH REPORT (PATIENT IDENTIFIER # (B)(6)) IS BEING SUBMITTED FOR THE OPERATIVE COMPLICATIONS ASSOCIATED WITH MULTIPORT SYSTEMS. TWO ADDITIONAL MEDWATCH REPORTS (PATIENT IDENTIFIER # (B)(6)) ARE SUBMITTED FOR CASE REPORTS OF INCISIONAL HERNIA MENTIONED IN THE SAME ARTICLE. ARTICLE CITATION: SA RA LEE, A-MI ROH, KYUNGAH JEONG, SUNG HOON KIM, HEE DONG CHAE, HYE-SUNG MOON, FIRST REPORT COMPARING THE TWO TYPES OF SINGLE-INCISION ROBOTIC SACROCOLPOPEXY: SINGLE SITE USING THE DA VINCI XI OR SI SYSTEM AND SINGLE PORT USING THE DA VINCI SP SYSTEM, TAIWANESE JOURNAL OF OBSTETRICS AND GYNECOLOGY, VOLUME 60, ISSUE 1, 2021. AVAILABLE AT HTTPS://DOI.ORG/10.1016/J.TJOG.2020.10.007. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S1028455920302564)" }, { "mdr_text_key": "319119480", "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 ¿FIRST REPORT COMPARING THE TWO TYPES OF SINGLE-INCISION ROBOTIC SACROCOLPOPEXY: SINGLE SITE USING THE DA VINCI XI OR SI SYSTEM AND SINGLE PORT USING THE DA VINCI SP SYSTEM,¿ THE FOLLOWING EVENTS WERE REPORTED: THE ARTICLE STUDY INCLUDED 48 PATIENTS WHO UNDERWENT SINGLE-SITE ROBOTIC SACROCOLPOPEXY (SS-RSC) USING DA VINCI SI OR XI SYSTEM FOR SYMPTOMATIC APICAL PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) STAGE III-IV BETWEEN NOVEMBER 2015 AND SEPTEMBER 2019 AND 8 PATIENTS WHO UNDERWENT SINGLE-PORT ROBOTIC SACROCOLPOPEXY (SP-RSC) USING THE DA VINCI SP SYSTEM DURING JANUARY 2019. THE OPERATIVE TIME WAS COMPARABLE BETWEEN SS-RSC AND SP-RSC GROUPS. PER THE ARTICLE, THERE WERE \"SIGNIFICANT DIFFERENCES WERE NOTED IN THE DOCKING AND CERVIX SUTURING TIMES BETWEEN THE TWO GROUPS (P < 0.05). THESE WERE LONGER IN THE SS-RSC GROUP THAN IN THE SP-RSC GROUP (5.0 ± 2.6 MIN VS 2.3 ± 1.3 MIN, P < 0.001; 4.5 ± 1.8 MIN VS 2.1 ± 1.9 MIN, P < 0.01, RESPECTIVELY). FURTHERMORE, \"THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS COMPARABLE AND BELOW 75.0 ML IN THE SS-RSC AND SP- RSC GROUPS (51.9 ± 33.7 ML VS 71.3 ± 41.2 ML).\" INTRAOPERATIVELY, THERE WAS NO TRANSFUSION OR CONVERSION TO LAPAROTOMY OR MULTI-PORT ROBOTIC SACROCOLPOPEXY (MP-RSC) IN EITHER GROUP. THE COMPLICATION RATES WERE NOT DIFFERENT BETWEEN THE TWO GROUPS ACCORDING TO THE AUTHOR'S ANALYSIS. THERE WAS NO CASE OF BOWEL OBSTRUCTION, DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, SEPSIS, CARDIAC, RESPIRATORY, RENAL, OR NEUROLOGICAL COMPLICATIONS. THERE WAS ONE CASE OF A BLADDER INJURY IN THE SP-RSC GROUP. PER THE ARTICLE, \"THE INTRAOPERATIVE PRIMARY REPAIR OF THE CYSTOTOMY SITE EXTENDED URINARY DRAINAGE WITH INDWELLING URETHRAL FOLEY CATHETER FOR 7 DAYS. REMOVAL OF THE FOLEY CATHETER AFTER CONFIRMING NO EXTRAVESICAL LEAKAGE OF THE DYE ON CYSTOGRAPHY RESOLVED THE ISSUE.\" POST-OPERATIVELY, THERE WAS 1 PATIENT WHO DEVELOPED FEVER AND REQUIRED READMISSION IN SP-RSC GROUP. THERE WAS ALSO ONE PATIENT WHO HAD POSTERIOR VAGINAL WALL MESH EROSION IN THE SP-RSC GROUP. THE EXPOSED MESH AND SURROUNDING VAGINAL WALL WERE REMOVED. A PRIMARY VAGINAL WALL CLOSURE WITH ABSORBABLE SUTURE MATERIAL, 2-0 VICRYL WAS PERFORMED. MEDICATION OF ORAL ESTRADIOL 2 MG ONCE DAILY WITH 0.03 MG ESTRIOL VAGINAL TABLET ONCE DAILY FOR 4 WEEKS WAS ADMINISTERED. THERE WAS NO MENTION OF MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES IN THE ARTICLE. 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": "" } ] }