{ "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": "2955842-2023-17079", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230714", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230615", "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": "20230714", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "179899", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230714", "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": "20250731", "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": "20230714", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Urinary Retention", "Obstruction/Occlusion", "Rectal Anastomotic Leakage", "Urinary Retention", "Obstruction/Occlusion", "Rectal Anastomotic Leakage" ] } ], "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": "17330076", "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": "319194593", "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 INCIDENTS CANNOT BE DETERMINED. ARTICLE CITATION: CHOI MS, YUN SH, OH CK, SHIN JK, PARK YA, HUH JW, CHO YB, KIM HC, LEE WY. LEARNING CURVE FOR SINGLE-PORT ROBOT-ASSISTED RECTAL CANCER SURGERY. ANN SURG TREAT RES. 2022 MAR;102(3):159-166. AVAILABLE AT : HTTPS://DOI.ORG/10.4174/ASTR.2022.102.3.159. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE MEAN AGE OF TOTAL PATIENT WAS 57.4 YEARS, AND MAJORITY (59.6 %) OF THE PATIENTS WERE MALE." }, { "mdr_text_key": "319194594", "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, ¿LEARNING CURVE FOR SINGLE-PORT ROBOT-ASSISTED RECTAL CANCER SURGERY¿, THE FOLLOWING EVENTS WERE REPORTED. FROM APRIL 2019 TO OCTOBER 2019, 57 SINGLE-PORT ROBOTIC (SPR)-ASSISTED RECTAL CANCER SURGERIES PERFORMED BY ONE SURGEON WERE INCLUDED IN THE STUDY. A TOTAL OF 57 PATIENTS (34 MALES, 59.6%) WERE TREATED FOR RECTAL CANCER AND INCLUDED 34 LOW ANTERIOR RESECTION(LAR) (59.6%), 14 ULTRA-LAR (24.6%), 7 INTERSPHINCTERIC RESECTION (ISR) (12.3%), AND 2 APR (ABDOMINOPERINEAL RESECTION) (3.5%) CASES. AMONG THESE, 11 PATIENTS ADDITIONALLY UNDERWENT ROBOTIC TRANSANAL TOTAL MESORECTAL EXCISION (TATME). THE MEAN AGE OF THE PATIENTS WAS 57.4 ± 10.1 YEARS, THE MEAN BMI WAS 24.5 ± 3.5 KG/M2, AND THE MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS (PS) CLASSIFICATION WAS II. THE MEAN VALUE OF TOTAL OPERATION TIME (OT) WAS 241.8 ± 91.7 MINUTES. THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS 158.4 ± 103.3ML. A TOTAL OF 23 COMPLICATIONS WERE IDENTIFIED IN THE PATIENTS WHO UNDERWENT SURGERY WHICH INCLUDES POSTOPERATIVE ILEUS, POSTOPERATIVE BLEEDING, CHYLOUS DRAIN COLOR CHANGE, AND URINARY RETENTION. THERE WERE 21 PATIENTS WITH CLAVIEN-DINDO GRADE I TO IIIA COMPLICATIONS AND 2 PATIENTS WITH CLAVIEN-DINDO GRADE IIIB TO IV COMPLICATIONS. THE MOST COMMON COMPLICATIONS WERE FLUID COLLECTION AND URINARY RETENTION (7 PATIENTS EACH). CLAVIEN-DINDO GRADE IIIB COMPLICATIONS COMPRISED 1 STOMAL REVISION DUE TO STOMA OBSTRUCTION AND 1 IRRIGATION AND LOOP ILEOSTOMY DUE TO ANASTOMOSIS LEAKAGE. ACCORDING TO THE ARTICLE AUTHOR, DUE TO THE DIFFICULTY OF THE SURGERY, THE SURGICAL TECHNIQUE WAS CHANGED FROM SPR-ASSISTED TO LAPAROSCOPIC IN 10 SURGERIES. 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": "" } ] }