{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2020-11373", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201218", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20201218", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1504418", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201218", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART", "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": "UNKNOWN", "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": "", "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", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "", "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": "20201218", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20201125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11039749", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201125", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "224761961", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED INFECTION CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AN ISI INSTRUMENT AND ACCESSORY (I&A) SUPPORT SPECIALIST INVESTIGATION HAS BEEN COMPLETED. THE SPECIALIST CONDUCTED A SITE VISIT AND REVIEWED THE CUSTOMERS¿ CLEANING PROCESSES AND MADE RECOMMENDATIONS FOR BEST PRACTICES. THE SPECIALIST ALSO PROVIDED THE CUSTOMER WITH A COMPETENCY CHECKLIST FOR INTERNAL TRAINING. SITE HISTORY REVIEW WAS CONDUCTED AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT HAS BEEN SUBMITTED FOR REVIEW AT THIS TIME. UNABLE TO PERFORM SYSTEM OR INSTRUMENT LOGS REVIEW WITH THE LACK OF PRODUCT AND PROCEDURE INFORMATION ON FILE AT THIS TIME. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: THERE WAS A REPORT OF A POST-OPERATIVE INFECTION FOLLOWING A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE BUT THERE WAS NO INFORMATION PROVIDED REGARDING THE SEVERITY OF THE INFECTION OR WHETHER OR NOT AN ISI PRODUCT CAUSED OR CONTRIBUTED TO THE COMPLICATION. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. ADDITIONALLY, THE ROOT CAUSE OF THE INFECTION CANNOT BE DETERMINED. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "224761962", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2019, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAD REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }