{ "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": "2955842-2022-12480", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220627", "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": [ "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": "609026", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220627", "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": "20250810", "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": "20220627", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "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": "14825746", "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": "295112212", "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 RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY¿ WAS UNABLE TO BE DETERMINED. ALTHOUGH, THE ARTICLE MENTIONED THAT THE PATIENT SUFFERED FROM RECTAL INJURY, IT IS UNKNOWN WHETHER THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION REQUIRED TO ADDRESS THE INJURY. MOREOVER, THE AUTHOR HAS NOT RESPONDED TO INTUITIVE SURGICAL, INC. (ISI) REQUESTS FOR ADDITIONAL EVENT INFORMATION. IN THIS CASE, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT. FURTHERMORE, THERE WAS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN ISI PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE ARTICLE. 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 RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY AND THAT THIS INFORMATION WAS RECEIVED FROM A CLINICAL JOURNAL ARTICLE WITH NO OTHER EVENT INFORMATION PROVIDED. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED INCIDENT REMAINS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IN SECTION IS NOT APPLICABLE. FIELD IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELDS AND ARE NOT APPLICABLE. FIELD IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "295112213", "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 RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY. ISI HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO THE REACH OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. 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. MOREOVER, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE ARTICLE." } ], "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": "" } ] }