{ "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": "2955842-2022-12416", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220625", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20210608", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20220627", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1267238", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220625", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "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": "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": "", "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": "20220625", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hematoma" ] } ], "distributor_city": "", "date_report": "20210608", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14813181", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210608", "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": "295110688", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY. ON 15-JUN-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT THE DURING PORT INCISION, THERE WAS A VESSEL (VEIN) INJURY. AS A RESULT, THE PATIENT EXPERIENCED A HEMATOMA. THE ESTIMATED BLOOD LOSS INTRA-OPERATIVELY WAS 250-500MLS. THERE WAS PROCEDURE FOR A WASHOUT AND HEMOSTASIS. THERE WAS NO BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. THE SURGEON HAD CONFIRMED THERE WAS NO RELATION TO THE DA VINCI PRODUCT. HOWEVER, IT IS UNKNOWN IF THE TROCAR WAS AN ISI PRODUCT OR A THIRD-PARTY PRODUCT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT." }, { "mdr_text_key": "295110689", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ALLEGED INCIDENT OF ¿ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY¿ WAS UNABLE TO BE DETERMINED. HOWEVER, BASED ON THE ADDITIONAL INFORMATION RECEIVED VIA FOLLOW-UP EMAIL, WHICH INDICATED THAT THE REPORTED INCIDENT WAS A RESULT OF THE PORT INCISION CAUSING INJURY TO THE VESSEL, MOST LIKELY VEIN. IT WAS FURTHER REPORTED BY THE CORRESPONDING AUTHOR THAT ¿THE PATIENT EXPERIENCED AN INTRA-OPERATIVE INADVERTENT INJURY OF THE BOWEL/RECTUM CAUSED BY SURGEON¿. THE INJURY WAS IDENTIFIED POST-OPERATIVELY AND THE PATIENT UNDERWENT RE-OPERATION AND DIRECT PRIMARY REPAIR. THERE WAS NO ADDITIONAL BLEEDING. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED AS THERE WAS LACK OF PRODUCT AND PROCEDURE INFORMATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO ADDITIONAL TECHNICAL REVIEW WAS REQUIRED AND/OR PERFORMED BASED ON THE COMPLAINT SINCE THE EVENT DATE, SITE NAME, AND DA VINCI SYSTEM INFORMATION ARE UNKNOWN. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ¿ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY¿. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED INCIDENT IS BELIEVED TO BE USE RELATED, AS RECEIVED INFORMATION INDICATED THAT THE INCIDENT WAS A RESULT OF THE PORT INCISION CAUSING INJURY TO THE VESSEL/VEIN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." } ], "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": "" } ] }