{ "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": "2955842-2020-10932", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200918", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200828", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "", "date_added": "20200918", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1016450", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200918", "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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/30/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20200918", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Nerve Damage", "Hernia", "Failure to Anastomose", "Nerve Damage", "Hernia" ] } ], "distributor_city": "", "date_report": "20210630", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10556557", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200828", "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": "325683266", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO THE FOLLOWING FIELD FOR CORRECTED INFORMATION: B3. REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: G3, G6, H2, AND H10. THE EVENT DATE HAS BEEN CORRECTED FROM \"(B)(6) 2020\" TO UNKNOWN." }, { "mdr_text_key": "325683267", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "207745176", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF EACH ALLEGED OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PRODUCTS ARE EXPECTED FOR RETURN TO ISI FOR EVALUATION. A COMPLAINT INVESTIGATION COULD NOT BE PERFORMED SINCE THE SITE AND PRODUCT INFORMATION COULD NOT BE COLLECTED AS PART OF THE BLIND SURVEY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED ABOUT THE EVENT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS CANNOT BE PERFORMED SINCE THE SITE NAME, PROCEDURE DATE, AND DA VINCI SYSTEM INFORMATION ARE UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE AND ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS. HOWEVER, THE SEVERITY OF EACH COMPLICATION IS UNKNOWN. IT IS ALSO UNCLEAR WHAT MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED FOR EACH COMPLICATION. IN ADDITION, ALTHOUGH THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. PATIENT INFORMATION ARE UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. NOT AVAILABLE FOR THE SITE AND INITIAL REPORTER SINCE THE INFORMATION CAME FROM A BLIND SURVEY. SPECIFIC PRODUCT INFORMATION WAS NOT PROVIDED AS PART OF THE BLIND SURVEY. THEREFORE THE INFORMATION COULD NOT BE OBTAINED." }, { "mdr_text_key": "207745177", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A JD POWER NPS/BRAND SPRING 2020 SURVEY, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INDICATING THAT A \"PATIENT HAS HAD SIDE EFFECTS SUCH AS ANASTOMOSIS INSUFFICIENCY, PORT-SITE HERNIA, BLEEDING, NERVE DAMAGE.\" NO OTHER CLINICAL INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE AND SEVERITY OF THE ALLEGED OPERATIVE COMPLICATIONS, WHAT MEDICAL INTERVENTION (IF ANY) WAS ADMINISTERED DUE TO THE OPERATIVE COMPLICATIONS, THE SITE NAME, THE PROCEDURE DATE, THE PROCEDURE OUTCOME, AND WHAT TYPE OF SURGICAL PROCEDURE WAS PERFORMED." } ], "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": "07/16/2021" } ] }