{ "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": "Death", "report_number": "2955842-2022-11468", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220507", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20220507", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1067596", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220507", "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": "20250801", "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": "20220507", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Viral Infection", "Viral Infection" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14325742", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200429", "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": "291193792", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURES, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH REPORTING PROFESSOR/SURGEON ON 29-APR-2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS PRIOR TO SURGERY AS CURRENT TEST RESULTS ARE UNRELIABLE. THE REPORTING PROFESSOR/SURGEON DID NOT HAVE ANY FURTHER INFORMATION REGARDING THE TWO CASES. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI FIELD SERVICE ENGINEERS IN THE AREA AND CONFIRMED THEY HAVE NOT RECEIVED ANY ASSOCIATED / SIMILAR ALLEGATIONS. ADDITIONALLY, THERE ARE NO KNOWN OR ALLEGED STERILIZATION ISSUES ASSOCIATED WITH COVID-19 AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE REGARDING THESE TWO CASES." }, { "mdr_text_key": "291193793", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, THERE ARE NO PRODUCT EXPECTED FOR RETURN TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTEM/INSTRUMENT LOG REVIEW CANNOT BE PERFORMED AT THIS TIME BECAUSE THE SYSTEM INFORMATION AND EVENT DATES ARE UNKNOWN. IT IS ALSO UNKNOWN IF THE REPORTED EVENTS EVEN INVOLVED A DA VINCI SURGICAL SYSTEM. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED UPON THE INFORMATION PROVIDED, IT IS UNCLEAR IF THE PATIENT UNDERWENT A DA VINCI-ASSISTED PROSTATECTOMY OR NOT. INFORMATION ABOUT SURGICAL DATE, SURGEON, HOSPITAL, ETC., ARE UNKNOWN AS THE REPORT WAS SECOND HAND. THE ONLY INFORMATION PROVIDED WAS THAT A PATIENT UNDERWENT A PROSTATECTOMY WAS COVID-19 NEGATIVE PRIOR TO THE CASE AND COVID-19 POSITIVE POST-OPERATIVELY AND THAT THE PATIENT EXPIRED. I AM UNABLE TO DETERMINE IF THE DA VINCI SYSTEM, INSTRUMENTATION, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE PATIENT¿S MORTALITY AS I HAVE NO EVIDENCE IF THE PROSTATECTOMY PROCEDURE WAS PERFORMED USING THE DA VINCI SYSTEM. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, THE PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT KNOW WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. WHILE THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE PROCEDURE, THE ROOT CAUSE OF THE REPORTED COMPLICATIONS REMAINS UNKNOWN. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR THE OTHER POST-OPERATIVE PATIENT DEATH ASSOCIATED WITH COVID-19." } ], "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": "" } ] }