{ "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": "2955842-2019-10802", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20191014", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20190913", "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": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20191014", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "978203", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191014", "brand_name": "DA VINCI", "generic_name": "CANNULA", "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": "420002-07", "catalog_number": "420002", "lot_number": "UNKNOWN", "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": "07/07/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20191014", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20190919", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9189157", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190919", "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": "325247757", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "325247758", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO THE FOLLOWING FIELD FOR CORRECTED INFORMATION: D2A, D4 (MODEL NUMBER, CATALOG NUMBER, LOT NUMBER, AND SERIAL NUMBER), AND G4. REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: G3, G6, H2, AND H10. THE PRODUCT INFORMATION HAS BEEN UPDATED TO PROVIDED CORRECTED INFORMATION." }, { "mdr_text_key": "162626220", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE FOLLOWING INFORMATION IS ALSO UNKNOWN: THE TYPE OF DAMAGE THAT WAS REPORTEDLY SUSTAINED ON THE PATIENT'S LIVER, THE SEVERITY OF THE REPORTED LIVER DAMAGE, AND WHAT MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED DUE TO THE REPORTED LIVER DAMAGE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT¿S LIVER WAS DAMAGED DURING PLACEMENT OF A DA VINCI PORT. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE REPORTED INTRA-OPERATIVE COMPLICATION IS UNKNOWN. IT IS ALSO UNCLEAR WHAT MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED DUE TO THE LIVER DAMAGE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI PRODUCT OCCURRED." }, { "mdr_text_key": "162626221", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, SEVERE BLEEDING FROM AN ADHESION SITE WAS OBSERVED DURING PLACEMENT OF AN ENDOSCOPE PORT WITH A 3RD-PARTY MANUFACTURER DEVICE. IN ADDITION, DURING INSERTION OF A DA VINCI PORT, THE ¿PORT¿ REPORTEDLY CAME IN CONTACT WITH THE PATIENT¿S LIVER. IT WAS REPORTED THAT THE PATIENT'S LIVER WAS DAMAGED. DUE TO SEVERE ADHESIONS AND THE DIFFICULTY OF SAFELY PLACING A PORT, THE CASE WAS CONVERTED TO OPEN SURGERY. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 10/14/2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT BLEEDING WAS OBSERVED DURING AN ATTEMPT TO PLACE A CAMERA PORT WITH A 3RD-PARTY MANUFACTURER PRODUCT. THERE WAS NO ALLEGATION THAT A DA VINCI PRODUCT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE ESTIMATED BLOOD LOSS IS UNKNOWN. NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BLEEDING. IN REGARDS TO PATIENT¿S LIVER, IT IS UNKNOWN IF A LIVER INJURY ACTUALLY OCCURRED. IT WAS NOTED THAT DURING INSERTION OF A CANNULA THROUGH A PORT, THE SURGEON FELT AS THOUGH THE TIP OF THE CANNULA MADE CONTACT WITH THE LIVER. THE PANCREATODUODENECTOMY WAS COMPLETED VIA OPEN SURGERY. THE PATIENT¿S CURRENT STATUS IS UNKNOWN." } ], "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": "08/01/2021" } ] }