{ "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": "2955842-2025-02208", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250226", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240828", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250226", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "419585", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250226", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20250226", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "62 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Seroma", "Unspecified Tissue Injury", "Seroma", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250204", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21468391", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250204", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "364442896", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: CHAVALI, J.S.; PEDRAZA, A.M.; SOPUTRO, N.A.; RAMOS-CARPINTEYRO, R.; MIKESELL, C.D.; KAOUK, J. SINGLE-PORT EXTRAPERITONEAL VS. MULTIPORT TRANSPERITONEAL ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY SCORE-MATCHED ANALYSIS. CANCERS 2024, 16, 2994. HTTPS://DOI.ORG/10.3390/CANCERS16172994 SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. TOTAL 429 PATIENTS' MEAN AGE WAS 62 YEARS, AND PATIENT GENDER WERE ALL MALES ACCORDING TO THE TYPE OF PROCEDURE. MAJORITY (85%) OF THE PATIENTS WERE WHITE. FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. 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. FIELD H4 IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "364442897", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE THAT DESCRIBED A STUDY THAT PROSPECTIVELY COLLECTED MEDICAL RECORDS OF 429 PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP) BETWEEN JANUARY 2015 AND OCTOBER 2023 USING THE SINGLE-PORT (SP) OR MULTI-PORT DA VINCI SYSTEM BY A SINGLE EXPERIENCED ROBOTIC SURGEON. THERE WERE NO CONVERSIONS TO OPEN SURGERY MENTIONED IN THE ARTICLE. THERE WAS ONE INTRAOPERATIVE COMPLICATION IN THE SP-RARP COHORT. THE INTRAOPERATIVE COMPLICATION OCCURRED DURING THE TRANSVESICAL (TV) RARP IN A PATIENT WITH A HISTORY OF A HOSTILE ABDOMEN. THERE WAS A SMALL ENTEROTOMY DURING THE INITIAL BLADDER ENTRY, WHICH WAS PROMPTLY IDENTIFIED AND REPAIRED PRIMARILY USING INTERRUPTED LEMBERT PERMANENT SUTURES BY GENERAL SURGERY. 23 PATIENTS REQUIRED RE-ADMISSION AFTER THE PROCEDURE, AND THE MAJORITY OF THE READMISSIONS IN THE SP COHORT WERE DUE TO POSTOPERATIVE FLUID COLLECTIONS THAT REQUIRED PERCUTANEOUS DRAINAGE. THE DRAINAGES WERE IDENTIFIED TO BE POSTOPERATIVE SEROUS COLLECTION AND NOT LYMPHOCELES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }