{ "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": "2955842-2023-10553", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230207", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230113", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230207", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190904", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "943475", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230207", "brand_name": "DA VINCI SP", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230130", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/13/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250808", "health_professional": "Y", "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": "20230207", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230113", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16315261", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230113", "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": "309014444", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, WHEN ATTEMPTING TO DOCK THEY WERE GETTING A CANNULA INVALID MESSAGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) AND ERROR 1162 PERSISTED. THE TSE REVIEWED ONSITE LOGS AND CONFIRMED ERROR CODE 1162. TSE THEN WALKED THE CALLER THROUGH ADDITIONAL EPO OF PSC AND POWERING SYSTEM BACK ON WITH CANNULA INSTALLED AND SYSTEM POWERED ON AND ERROR DID NOT PERSIST. THE CALLER REPORTED THAT THE SURGEON HAD PERFORMED THE SURGERY ¿MANUALLY¿ AND THE CASE WAS COMPLETED WITHOUT THE DAVINCI ROBOT. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON¿S NAME WAS PROVIDED. THE SURGEON WAS REQUIRED TO CHANGE THE SURGICAL APPROACH TO OPEN SURGERY. THERE WAS NO INJURY TO THE PATIENT." }, { "mdr_text_key": "309014445", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON THE FIELD SERVICE EVALUATION, THE FSE WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED ISSUE. THE FSE TRIED REPLACING THE SOAM BOARD C, THE CANNULA MOUNT, AND THE SCID BUT DESPITE THE EFFORTS, THE ISSUE PERSISTED. THE RESOLUTION WAS TO PLACE KAPTON TAPE OVER THE METAL SECTION WHERE THE SCID IS MOUNTED. THE SYSTEM TEST DRIVE WAS COMPLETED WITHOUT ERROR AND THE CUSTOMER REPORTED THAT NO ISSUES OBSERVED DURING THE NEXT DAY CASES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SOAM BOARD C INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE SOAM UNIT WAS RETURN FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. THE UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT WORKED FINE. THE UNIT WAS POWER CYCLED TEN TIMES AND EXERCISED ALL INSTRUMENTS CUT/SEAL PASS WITHOUT ANY ISSUE. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED AND INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED TO HAVE THE CANNULA MOUNT UNIT BE RETURNED FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN SURGERY AFTER THE START OF THE PROCEDURE DUE TO ¿CANNULA INVALID¿ ERROR MESSAGE. COMPLAINT INVESTIGATION ALSO CONFIRMED THAT THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SOAM BOARD C, THE CANNULA MOUNT, AND THE SCID ASSEMBLY TO RESOLVE THE ISSUE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MDR WILL BE SUBMITTED." }, { "mdr_text_key": "334192615", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CANNULA MOUNT WAS ANALYZED AND FOUND UPON VISUAL INSPECTION THERE WAS NO OBVIOUS DEFECTS ON THE ASSEMBLY. THE CANNULA MOUNT ACTUATES AS EXPECTED. THE TROUBLESHOOTING PROCESS PERFORMED BY THE FIELD SERVICE ENGINEER DEMONSTRATED THAT THE MECHANICAL FUNCTION OF THE CANNULA MOUNT ASSEMBLY WAS NOT THE SOURCE OF THE FAULT. THE CANNULA MOUNT WAS REPLACED WITH A NEW UNIT AND WAS STILL DISPLAYING THE \"CANNULA INVALID\" MESSAGE. AFTER THE RECOMMENDED INSTALLATION OF KAPTON TAPE, THE ISSUE WAS RESOLVED." }, { "mdr_text_key": "334192616", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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": "03/08/2023" } ] }