{ "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": "2955842-2017-00735", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20171103", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20171019", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171103", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "779106", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171103", "brand_name": "DA VINCI SI 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": "IS3000, A60P9B", "catalog_number": "", "lot_number": "", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20171103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20171019", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7001607", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171019", "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": "91055295", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ROOT CAUSE OF THE REPORTED INTRA-OPERATIVE BLEEDING CANNOT BE DETERMINED. THE SITE WAS UNWILLING TO PROVIDE ANY INFORMATION REGARDING THE INTRA-OPERATIVE COMPLICATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE SITE'S SYSTEM LOGS WERE REVIEWED WITH A PROCEDURE DATE OF (B)(6) 2017. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE SURGEON REPORTEDLY CONVERTED THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO A TRADITIONAL SURGICAL PROCEDURE IN ORDER TO CONTROL BLEEDING. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE BLEEDING IS UNKNOWN. THERE IS NO ALLEGATION BY THE SITE OR THE SURGEON THAT AN ISI DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INTRA-OPERATIVE BLEEDING OR THAT AN ISI DEVICE MALFUNCTIONED." }, { "mdr_text_key": "91055296", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE SURGEON NICKED THE BRANCHES OF THE CAROTID ARTERY. AS A RESULT, THE PATIENT EXPERIENCED A SIGNIFICANT AMOUNT OF BLEEDING AND THE SURGEON HAD TO CONVERT THE PROCEDURE TO A TRADITIONAL SURGICAL PROCEDURE TO CONTROL THE BLEEDING. THE PATIENT WAS IN THE INTENSIVE CARE UNIT WHEN THE EVENT WAS REPORTED TO INTUITIVE SURGICAL, INC. (ISI). HOWEVER, THERE IS NO ALLEGATION BY THE SITE OR THE SURGEON THAT AN ISI DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR THAT AN ISI DEVICE MALFUNCTIONED. ON OCTOBER 24 AND 26, 2017, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT THE SURGEON WAS USING THE MONOPOLAR CAUTERY AND THE SCHERTEL GRASPER INSTRUMENTS WHEN THE BLEEDING OCCURRED. THE CSR STATED THAT THE EXTERNAL CAROTID ARTERY BRANCH WAS NICKED AND SHE COULD NOT CONFIRM THE CAUSE. AS A RESULT, THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING AND THE PROCEDURE WAS CONVERTED TO A TRADITIONAL SURGICAL PROCEDURE TO CONTROL THE BLEEDING. SINCE THE CSR LEFT THE ROOM AFTER THE ROBOTIC PORTION OF THE PROCEDURE, SHE COULD NOT CONFIRM HOW THE BLEEDING WAS CONTROLLED. THE CSR COULD NOT QUANTIFY THE AMOUNT OF BLEEDING; HOWEVER, SHE CONFIRMED THAT THERE WAS AN UNSPECIFIED AMOUNT BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. THE CSR REPORTED THAT THE SURGEON CONFIRMED THAT THE PATIENT IS RECOVERING VERY WELL. THE CSR CONFIRMED THAT THERE WAS NO VIDEO RECORDING OF THE PROCEDURE. ON (B)(6) 2017, ISI CONTACTED THE SITE TO GATHER ADDITIONAL INFORMATION; HOWEVER, THE SITE WAS UNWILLING TO PROVIDE ANY INFORMATION REGARDING THE INTRA-OPERATIVE COMPLICATION." } ], "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": "" } ] }