{ "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": "HOSPITAL", "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": "2955842-2012-00566", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20121012", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20121015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121012", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "", "catalog_number": "", "lot_number": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20121012", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM INSTRUMENT & ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection" ] } ], "distributor_city": "", "date_report": "20120912", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2786589", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120912", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "20793410", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED INFORMATION FROM DR (B)(6), THE (B)(6) AT (B)(6) HOSPITAL, CONCERNING A POSTING ON AN ONLINE UROLOGY FORUM CALLED (B)(4) REGARDING AN ODD GERM. THE POSTING WAS DATED (B)(6) 2012 AND THE AUTHOR WAS DR. (B)(6). DR. (B)(6) INDICATED THAT A PATIENT, (B)(6) UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE USING THE DA VINCI SURGICAL SYSTEM. DR. (B)(6) INDICATED THAT THE PATIENT WAS HOSPITALIZED FOR 8 DAYS AND THERE WAS AN ABSENCE OF ANY PATHOLOGICAL FINDINGS AFTER THE SURGERY PROCEDURE. DR. (B)(6) INDICATED THAT THE PATIENT'S HISTOLOGY WAS PT2 N0 GL 7APSA 5.7 NG. DR. (B)(6) INDICATED IN THE POSTING AFTER 11 WEEKS CLINICAL INFECTION, BACTEREMIA WITH BACTEROIDES FRAGILIS IN THE BLOOD CULTURE (FACULTATIVE PATHOGENIC BACTERIA). CAUSE WAS AN INFECTED LYMPHOCELE, IN THE PUNCTUATION ALSO BACTEROIDES FR. DR. (B)(6) ALSO INDICATED IN THE POSTING THEREFORE AN UNUSUAL GERM, PROMINENT PROTRACTED DEVELOPMENT. ISOLATED CASE? CONNECTION WITH METHOD? NO OTHER INFORMATION CONCERNING THE REPORTED INCIDENT WAS PROVIDED." }, { "mdr_text_key": "21032114", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS MADE MULTIPLE ATTEMPTS TO CONTACT DR. (B)(6); HOWEVER, NO RESPONSE HAS BEEN RECEIVED; THEREFORE THE ROOTCAUSE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "" } ] }