{ "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": "2955842-2023-17031", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230713", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20201215", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "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": "312836", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "64 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hypovolemic Shock", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Hypovolemic Shock", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17318145", "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": "319091194", "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, ¿SINGLE PORT ROBOTIC RADICAL PROSTATECTOMY VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY: A HUMAN FACTOR ANALYSIS DURING THE INITIAL LEARNING CURVE¿ THE FOLLOWING EVENTS WERE REPORTED: FROM (B)(6) 2018 TO (B)(6) 2019, THE FIRST 20 CONSECUTIVE SINGLE PORT (SP) ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMIES (RALPS) PERFORMED BY A SINGLE EXPERIENCED ROBOTIC SURGEON WERE COMPARED AGAINST 20 MULTIPORT (MP) RALPS PERFORMED AT ANOTHER SITE IN ITALY. OF THE 20 CASES THAT WERE PERFORMED USING THE DA VINCI SINGLE PORT (SP), ONE INTRA-OPERATIVE COMPLICATION OF SEROSAL INJURY DUE TO EXTENSIVE LYSIS OF ADHESIONS WAS REPORTED. EIGHTEEN POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE, WHICH INCLUDES CLAVIEN-DINDO GRADE I TO GRADE IVB. EIGHT PATIENTS DEVELOPED GRADE I POST-OPERATIVE COMPLICATIONS INVOLVING SHOULDER PAIN, ILEUS, ELECTROLYTE DERANGEMENT, NAUSEA, AND/OR VOMITING. SIX PATIENTS EXPERIENCED GRADE II COMPLICATIONS INVOLVING URINARY TRACT INFECTION (UTI), HEALTHCARE ACQUIRED PNEUMONIA (HCAP), EPIDIDYMOORCHITIS, AND/OR PELVIC HEMATOMA WHICH REQUIRED TRANSFUSION. TWO PATIENTS HAD GRADE III POST-OPERATIVE COMPLICATIONS INVOLVING URINE LEAK THAT REQUIRED PERCUTANEOUS NEPHROSTOMY (PCN) PLACEMENT AND THE OTHER PATIENT REQUIRED PLACEMENT OF A GASTROSTOMY TUBE (G TUBE). TWO PATIENTS WERE REPORTED EXPERIENCING GRADE IV COMPLICATIONS. ONE OF THE PATIENTS WAS REPORTED HAVING EXTENDED INTUBATION, AND PRESSORS REQUIRING CRITICAL CARE (ICU) AND DEVELOPED HYPOTENSIVE SHOCK. A PATIENT REQUIRED EXPLORATORY LAPAROTOMY WITH URINE LEAK IDENTIFIED AFTER SLIGHT DEHISCENCE OF POSTERIOR ANASTOMOSIS. IT WAS ALSO MENTIONED URETERAL STENTS AND BILATERAL PCNS WERE REQUIRED FOR URINARY DIVERSION. ONE OF THE PATIENTS ALSO EXPERIENCED ASPIRATION WITH BACTEREMIA AND ENDOCARDITIS. THERE WERE NO MENTION OF MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES IN THE ARTICLE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, THE AUTHOR INDICATED THAT NO ADDITIONAL INFORMATION ARE AVAILABLE." }, { "mdr_text_key": "319091195", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT A DA VINCI 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. THIS MEDWATCH REPORT (PATIENT IDENTIFIER (B)(6) IS SUBMITTED FOR THE REPORTED OPERATIVE COMPLICATIONS ASSOCIATED WITH SINGLE PORT SYSTEM SURGERIES. A SEPARATE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) IS SUBMITTED FOR THE SERIOUS INJURY POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH MULTIPORT SYSTEM SURGERIES MENTIONED IN THE SAME ARTICLE. ARTICLE CITATION: TALAMINI S, HALGRIMSON WR, DOBBS RW, MORANA C, CRIVELLARO S. SINGLE PORT ROBOTIC RADICAL PROSTATECTOMY VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY: A HUMAN FACTOR ANALYSIS DURING THE INITIAL LEARNING CURVE. INT J MED ROBOT. 2020;E2209. AVAILABLE AT : HTTPS://DOI.ORG/10.1002/RCS.2209. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FIELD A2 REFLECTS THE THE MEAN AGE OF THE PATIENTS AND FIELD A6 REFLECTS THE ETHNICITY OF THE MAJORITY (50%) OF THE PATIENTS. 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. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE." } ], "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": "" } ] }