{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2023-18541", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230919", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20230823", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20230919", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220131", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "150064", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230919", "brand_name": "DA VINCI XI", "generic_name": "VISION SIDE SYSTEM, RECONDITIONED", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380721-11", "catalog_number": "380721", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874115343", "udi_public": "(01)00886874115343", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "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": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20230919", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230823", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17773279", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230823", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "323723689", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR 316. THE CUSTOMER DID NOT MANAGE TO CALL TECHNICAL SUPPORT AND AFTER SEVERAL TRIES, THE CUSTOMER DECIDED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC APPROACH BECAUSE THE SYSTEM ISSUE COULD NOT BE SOLVED IN 30 - 40 MINUTES AND THE SURGEON HAD A BUSY SCHEDULE AFTER, THE CUSTOMER COULD NOT WAIT MORE TIME. THE SURGERY WAS PERFORMED LAPAROSCOPICALLY. AN INCISION WAS MADE TO EXTRACT THE SPECIMEN AND TO PERFORM AN EXTRA CORPORAL ANASTOMOSIS (AS THE SURGEON USUALLY DOES IN LAPAROSCOPY). BUT IF THE SURGERY WERE PERFORMED ROBOTICALLY, THE SURGEON WOULD HAVE PROBABLY PERFORMED AN INTRACORPORAL ANASTOMOSIS, AND MAKE A SMALL INCISION TO EXTRACT THE SPECIMEN. THE ISSUE WAS NOT SOLVED WHEN THE SURGEON PLACED THE ROBOTIC CANNULAS IN THE PATIENT. THE EVENT OCCURRED AFTER INCISION AND PORT PLACEMENT. NO OTHER SURGICAL TASKS PERFORMED BEFORE THE SYSTEM ISSUE. THE CUSTOMER NOTED THAT THE OPERATION WAS PROLONGED FOR AROUND 30 MINUTES WHILE TRYING TO SOLVE THE ISSUE. THE OPERATION WAS NOT PROLONGED BY 15 MINUTES OR MORE DURING WARM ISCHEMIA AS A RESULT OF THIS ISSUE. THE LENGTH OF SURGICAL PROCEDURE WAS 2 HOURS AND 30 MINUTES. THERE WAS NO COMPLICATION DUE TO THE DELAY. THE SURGEON HAD TO MAKE A LARGER INCISION AT THE END OF THE PROCEDURE TO EXTRACT THE SPECIMEN AND ESPECIALLY TO FINISH THE RIGHT COLIC FLEXURE MOBILIZATION. NO POST-OPERATIVE COMPLICATIONS ACCORDING TO THE SURGEON. THE PATIENT WAS TREATED LAPAROSCOPICALLY. THE SURGEON WAS NOT CONCERNED ABOUT THE PROCEDURE DELAY CAUSING ANY LONG-TERM COMPLICATIONS WITH THE PATIENT." }, { "mdr_text_key": "323723690", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED PORT 2 WAS PHYSICALLY DAMAGED AND REPLACED THE BLUE FIBER CONNECTOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }