{ "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": "2955842-2024-15335", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240613", "manufacturer_address_2": "", "pma_pmn_number": "K171426", "date_of_event": "20240507", "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": "408", "date_added": "20240613", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "784397", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240613", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE", "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": "470027-62", "catalog_number": "470027", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240528", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874112212", "udi_public": "(01)00886874112212", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended Movement", "Unintended Movement" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/17/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20240613", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20240515", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19531793", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240515", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "346884757", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE BLEEDING WAS ALREADY OCCURRING DURING THIS PROCEDURE AND WAS NOT CAUSED BY A DA VINCI PRODUCT. THE SURGEON WAS REPORTEDLY TRYING TO MOVE THE ENDOSCOPE TO VIEW THE ANATOMY, AND THE UNIVERSAL SURGICAL MANIPULATOR (USM) THE ENDOSCOPE WAS ON WAS MOVED IN SUCH A WAY THAT THE ENDOSCOPE BECAME BENT. THE BLEEDING NOT CAUSED BY UNEXPECTED MOVEMENT OF AN ISI PRODUCT. THE BLEED WAS NOT EXPECTED, BUT WAS CONSIDERED MINIMAL. CAUTERY WAS USED TO CONTROL THE BLEEDING. NO BLOOD TRANSFUSIONS WERE ADMINISTERED DUE TO THIS BLEEDING AND THE BLEEDING DID NOT LEAD TO SERIOUS DETERIORATION OR CLINICAL INSTABILITY OF THE PATIENT. THIS EVENT LED TO THE OR STAFF RETRIEVING A BACK-UP INSTRUMENT WHICH TOOK OVER FIVE MINUTES TO RETRIEVE. THE 30 DEGREE ENDOSCOPE WAS RECEIVED FOR FAILURE ANALYSIS TESTING. THE ENDOSCOPE WAS EVALUATED AND PLACED ON A DIAGNOSTIC TESTER OR EQUIVALENT FOR FUNCTIONAL TESTING. THE LIGHT LEAKAGE TEST OR EQUIVALENT WAS PERFORMED TO DETECT IF ANY IMAGE QUALITY DEFECT(S) WERE DETECTED IN EITHER OR BOTH EYES. THE ENDOSCOPE WAS FOUND WITH AN ARTIFACT(S) IN THE RIGHT EYE AND LEFT EYE. THE ENDOSCOPE WAS ALSO PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING." }, { "mdr_text_key": "346884758", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "344769477", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE 30-DEGREE 8MM ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE ISSUE OCCURRED WHILE THE SURGEON WAS TRYING TO VIEW OMENTUM THAT WAS BLEEDING. AS A RESULT, THE SURGEON HAD DIFFICULTY VIEWING THE SURGICAL FIELD DUE TO THE ENDOSCOPE MOTION ISSUE. THE CAUSE, SEVERITY, AND BLOOD LOSS VOLUME OF THE BLEEDING ARE UNKNOWN. IT IS ALSO UNKNOWN IF ANY MEDICAL INTERVENTION WAS RENDERED DUE TO THE BLEEDING. THIS ENDOSCOPE WAS REPLACED WITH ANOTHER TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS REPORTEDLY COMPLETED ROBOTICALLY." }, { "mdr_text_key": "344769478", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 30-DEGREE 8MM ENDOSCOPE INSTRUMENT FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE FAILURE ANALYSIS INVESTIGATION HAS NOT YET BEEN COMPLETED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/15/2024" } ] }