{ "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": "2955842-2023-15444", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230601", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20210428", "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", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230601", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190826", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1130676", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230601", "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": "20210510", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Difficult to Remove", "Failure to Sense", "Difficult to Remove", "Failure to Sense" ], "reporter_state_code": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20230601", "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": "20210428", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17039788", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210428", "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": "316387719", "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. THE FSE FOUND A BROKEN PIN ON THE PATIENT SIDE MANIPULATOR (PSM). THE FSE REPLACED THE PSM DUE TO A BROKEN PRESENCE PIN. REPLACING THE PSM RESOLVED THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED/REPLICATED THE REPORTED EVENT. VISUAL INSPECTION, THE INSTRUMENT PRESENCE PIN WAS FOUND BROKEN. AS A FIX, THE STERILE ADAPTER MOUNT ASSEMBLY WILL BE REPLACED TO ADDRESS THE REPORTED PROBLEM AND THE SSFM PCA WILL ALSO BE REPLACED TO ACCOMMODATE THE STERILE MOUNT REPLACEMENT DURING REPAIR. THE UNIT WAS ALSO TESTED ON PFTP AND PASSED SERVO TEST, PRELOAD MOTOR HEALTH CHECK, SINE CYCLE, CLUTCH BUTTON CHECK, CHECK DISPLAY, BRAKE SPEC, BRAKE REPEATABILITY, FRICTION TEST, SMOOTHNESS TEST, AND BELT PROOF LOAD TEST." }, { "mdr_text_key": "316387720", "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 CUSTOMER CALLED IN TO REPORT THAT THEY COULD NOT REMOVE AN INSTRUMENT FROM ARM 1. THE TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED TO PRESS THE INSTRUMENT DRIVE RELEASE BUTTON, AND THE CUSTOMER STATED THAT SHE HAD ALREADY TRIED THAT. THE TSE ADVISED TO PRESS THE EMERGENCY-STOP BUTTON ON THE PATIENT SIDE CART (PSC), AND THE CUSTOMER STATED THAT THEY HAD ALREADY MOVED THE PSC AWAY FROM THE PATIENT. THE TSE INSTRUCTED THE CUSTOMER TO PRESS THE RELEASE TABS AND WIGGLE THE PATIENT SIDE MANIPULATOR (PSM), AND THE CUSTOMER STATED THAT IT WAS NOT MOVING. THE CUSTOMER REPORTED THAT THEY FINALLY WERE ABLE TO REMOVE THE INSTRUMENT. THE TSE INSTRUCTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER AND TRY A TRAINING INSTRUMENT. THE CUSTOMER RESEATED THE INSTRUMENT ARM DRAPES, CONFIRMED THE DISCS WERE SPINNING, AND INSTALLED THE TRAINING INSTRUMENT. IT WAS NOTED THAT PSM 1 STILL HAD A YELLOW LIGHT EMITTING DIODE (LED), AND THE TRAINING INSTRUMENT WAS NOT RECOGNIZED. THE TSE HAD THE CUSTOMER REMOVE THE TRAINING INSTRUMENT AND STERILE ADAPTER, AND THE CUSTOMER REPORTED THAT ONE OF THE INSTRUMENT PRESENCE PINS ON PSM 1 WAS BROKEN/STUCK. THE TSE NOTED THAT THE CUSTOMER CONVERTED THE CASE PRIOR TO CONTACTING TECHNICAL SUPPORT. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME." } ], "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": "" } ] }