{ "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": "2955842-2026-16865", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20260319", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260225", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260319", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200429", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "206673", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260319", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260303", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "No Device Output" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/25/2026;03/26/2026;05/25/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "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": "20260319", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260618", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24644199", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260225", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "405538061", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: THE SURGEON INDICATED THAT THE PATIENT IS DOING WELL." }, { "mdr_text_key": "405538062", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "399588899", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H11. ADDITIONAL INFORMATION: THE PROCEDURE WAS A SIMPLE PROSTATECTOMY. THE CUSTOMER CONFIRMED THE SUMMARY OF EVENTS. IT WAS REPORTED THAT THERE WERE NO SYSTEM MALFUNCTIONS PRIOR TO THE START OF THE PROCEDURE. THE SINGLE PORT (SP) SYSTEM WAS IN USE FOR APPROXIMATELY 30 MINUTES BEFORE THE REPORTED EVENT OCCURRED. THE PROCEDURE CONVERSION WAS DUE TO THE SP SYSTEM NOT WORKING PROPERLY. IT WAS REPORTED THE PATIENT TOLERATED THE CONVERSION WITHOUT INJURY. THE CUSTOMER STATED THERE HAVE BEEN NO REPORTS OF POST-OP COMPLICATIONS BUT WERE UNABLE TO DISCLOSE THE PATIENT'S CURRENT STATUS." }, { "mdr_text_key": "399588900", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "396601299", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: B1, B2, B5, H1, H2, H6, H11 THE SITE'S ROBOTICS COORDINATOR PROVIDED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE PROCEDURE COULD NOT BE COMPLETED ROBOTICALLY AND WAS CONVERTED TO OPEN SURGERY." }, { "mdr_text_key": "396601300", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "396664357", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE CAMERA WOULD NOT ENGAGE WITH THE CAMERA PATIENT SIDE MANIPULATOR (PSM). MID CASE THE CAMERA WAS REMOVED TO BE CLEANED. DURING REINSTALLATION THE CAMERA WOULD NOT ENGAGE AND KEPT FALLING OUT. THE CUSTOMER RESEATED THE DRAPE AND THE ISSUE REMAINED. THE CUSTOMER THEN REPLACED THE DRAPE, BUT THE CAMERA STILL WOULD NOT ENGAGE. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER CHECK THE PRESENCE PINS AND ACTUATE ALL OF THEM. THE CUSTOMER INSTALLED THE STERILE ADAPTER, BUT IT KEPT DISENGAGING ON ONE SIDE. THE TSE HAD THE CUSTOMER FORCEFULLY ENGAGE THE ADAPTER AND STILL THE ISSUE REMAINED. THE CUSTOMER DECIDED TO POWER CYCLE THE SYSTEM, BUT THAT DID NOT HELP. THE TSE ASKED HOW THE CUSTOMER WAS GOING TO FINISH THE CASE. THE CUSTOMER STATED THEY WERE NOT SURE AND ENDED THE CALL. PRIOR TO DISCONNECTING THE CALL, THE CUSTOMER DID MENTION THAT ALL OF THE OTHER DA VINCI SYSTEMS WERE IN USE. THERE WERE NO REPORTS OF PATIENT INJURY." }, { "mdr_text_key": "396664358", "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 EVENT. THE FSE REPLACED PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE REPLACED PSM HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. THE REPORTED ISSUE WAS CONFIRMED BUT NOT REPLICATED. IN THE SYSTEM LOGS, MULTIPLE 31009 AND 31010 (INSTRUMENT AND STERILE ADAPTER RECOGNITION) ERRORS WERE FOUND. DURING VISUAL INSPECTION, MINOR FRICTION WAS FOUND ON BOTH RETENTION PLATE SPRING PINS. THE UNIT WAS INSTALLED ONTO A TESTING SYSTEM. THE STERILE ADAPTER USED WOULD COME OFF INTERMITTENTLY. DESPITE THE RETENTION ISSUES, MULTIPLE STERILE ADAPTERS AND CAMERAS/INSTRUMENTS WERE ABLE TO BE INSTALLED ON THE PSM WITHOUT ANY ERRORS. ALL TESTS PERFORMED WERE FOUND TO BE WITHIN SPECIFICATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/25/2026;04/16/2026;06/18/2026" } ] }