{ "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-35106", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260819", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250902", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Foreign", "Study", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260819", "manufacturer_contact_f_name": "Izabel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "286116", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260819", "brand_name": "Da Vinci", "generic_name": "Da Vinci Surgical System", "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": "N/A", "catalog_number": "N/A", "lot_number": "Unknown", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260831", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260819", "sequence_number_treatment": [ "da Vinci Instruments and Accessories" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Sepsis", "Unspecified Kidney or Urinary Problem" ] } ], "distributor_city": "", "date_report": "20260722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50313427", "removal_correction_number": "N/A", "number_devices_in_event": "", "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": "15512297441", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A clinical literature study evaluated the oncological and functional outcomes after salvage robotic-assisted laparoscopic radical prostatectomy (sRALP). The study consisted of 60 patients who were consecutively treated with sRALP for radiorecurrent prostate cancer (PCa). The data was collected from a hospital registry and electronic patient journals (EPJ) between 2013 and 2021 from one hospital site. Post surgical complications included, 15 patients with urinary stricture required surgical intervention. During the follow-up period, 11 patients received an artificial urinary sphincter, and 10 patients underwent urinary diversion. In total, 19 patients were treated with either an artificial urinary sphincter and/or urinary diversion. In addition, 2 patients developed pelvic osteomyelitis, requiring multiple surgical and medical interventions, ultimately leading to urinary diversion. Two patients suffered urinary sepsis, one of them due to iatrogenic small bowel perforation, one had a lung embolus, one experienced a stroke, and nine patients required antibiotics due to infections.It was concluded that sRALP for radiorecurrent PCa has limited effect on oncological outcomes. It was recommended that patients should be thoroughly informed about the high risk of urinary leakage and severe surgical complications.Per the author, the complications reported in the publication, did not show any evidence suggesting that these complications were caused by or associated with malfunction of any Intuitive Surgical, Inc. (ISI) device. Consequently, there was no evidence that the reported complications were caused or contributed to by any ISI device and they were not aware of any da Vinci device malfunctions associated with the procedures described in the publication.The study was a retrospective review of patients treated between 2013 and 2021. Additional case-specific information, including detailed device information, was not collected or reported as part of the publication and therefore cannot readily be provided." }, { "mdr_text_key": "16012297443", "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. No image(s) and/or video clip(s) associated with this reported event were reviewed.Habberstad, A., Stokke, S., Eri, L. M., Diep, L. M., Brennhovd, B., & Berge, V. (2025). Oncological outcomes and complications after salvage robotic-assisted laparoscopic radical prostatectomy (sRALP). Scandinavian Journal of Urology, 60, 158¿163. https://doi.org/10.2340/sju.v60.44585Median age at the time of RT was 60 years (IQR 56¿63)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }