{ "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": "2955842-2025-48376", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251212", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20251117", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20251213", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1638529", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251212", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251212", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening", " H", " R" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Coma", "Unspecified Gastrointestinal Problem", "Unspecified Tissue Injury", "Coma", "Unspecified Gastrointestinal Problem", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251212", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23796701", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251118", "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": "387610562", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING ROUTINE MEDIA MONITORING, AN ARTICLE WAS IDENTIFIED REPORTING SEVERE COMPLICATIONS FOLLOWING A DA VINCI-ASSISTED PROSTATECTOMY. THE PATIENT STATED THAT THE PROSTATE WAS REMOVED USING THE DA VINCI ROBOTIC SURGICAL SYSTEM. POST-OPERATIVELY, SERIOUS COMPLICATIONS OCCURRED AS A RESULT OF THE SMALL INTESTINE BEING DAMAGED DURING THE PROCEDURE, NECESSITATING AN EMERGENCY SURGERY OVERNIGHT. AS A RESULT, THE PATIENT WAS IN A COMA FOR ONE WEEK AND REMAINED HOSPITALIZED FOR APPROXIMATELY THREE AND A HALF WEEKS. NO ALLEGATIONS WERE MADE REGARDING DEVICE MALFUNCTIONS OR DIRECT CAUSATION BY THE DA VINCI SYSTEM." }, { "mdr_text_key": "387610563", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. A REQUEST FOR ADDITIONAL EVENT INFORMATION WAS SUBMITTED TO THE CORRESPONDING AUTHOR. THE JOURNALIST STATED THAT THE PATIENT DOES NOT WISH TO SHARE DETAILS ABOUT THE CASE. CITATION: KEIMEL, M. (17-NOV-2025). \"ICH DACHTE, DAS IST DAS ENDE\" - EIN BETROFFENER UBER DIE SCHOCK-DIAGNOSE PROSTATAKREBS. BERLINER ZEITUNG. HTTPS://BERLINER-ZEITUNG.DE/OPEN-SOURCE/ICH-DACHTE-DAS-IST-DAS-ENDE-EIN-BETTROFFENER-ERZAEHLT-UEBER-DEN-SCHOCK-SEINER-KREBSDIAGNOSE-LI.10004191 SECTION B3: THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. SECTION B4: CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 18-NOV-2025. SECTION D4: THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS; THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE. SECTION E1: SINCE THIS ARTICLE WAS IDENTIFIED DURING A SOCIAL MEDIA REVIEW BY INTUITIVE SURGICAL, INC. (ISI), RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE REPORTER." } ], "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": "" } ] }