{ "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": "2955842-2025-29306", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250710", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250620", "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": "20250710", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230225", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1908896", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250710", "brand_name": "DA VINCI", "generic_name": "CANNULA, STANDARD, REUSABLE", "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": "470002-07", "catalog_number": "470002", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874112137", "udi_public": "(01)00886874112137(10)NA", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Separation" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/11/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251119", "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": "20250710", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "42 YR", "patient_sex": "Female", "patient_weight": "80 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250620", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22469190", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250620", "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": "374594641", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP WAS BENT, AND A PIECE OF THE BLACK PART FELL INSIDE THE PATIENT, BUT THE DOCTOR RETRIEVED IT. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "374594642", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CANNULA SEAL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "383521891", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CANNULA/SEAL WERE RETURNED STILL ATTACHED TO A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THEY WERE ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. AN INVESTIGATION WAS COMPLETED. NO DAMAGE WAS FOUND. ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER REGARDING THE COMPLAINT: A FENESTRATED BIPOLAR ARM WAS IN USE DURING A ROBOTIC ASSISTED LAPAROSCOPIC MYOMECTOMY CASE. THE ARM STOPPED MOVING AND THE FIRST ASSIST SAW THAT THE TIP OF THE ARM WOULD NOT STRAIGHTEN OUT. AN EMERGENCY INSTRUMENT RELEASE DEVICE WAS RETRIEVED AND USED IN AN ATTEMPT TO TAKE THE ARM OUT THROUGH THE TROCAR BUT IT WAS UNSUCCESSFUL. DUE TO THE FACT THAT THE ARM COULD NOT STRAIGHTEN OUT COMPLETELY, THE ONLY WAY TO TAKE IT OUT WAS TO TAKE THE ENTIRE TROCAR OUT ALONG WITH THE ARM. UPON EXIT, A PIECE OF THE WIRE THAT HAD SNAPPED, BROKE OFF AND WENT INTO THE INTERIOR OF THE ABDOMINAL WALL. IT WAS SPOTTED AND RETRIEVED EASILY LEAVING NO DAMAGE. A NEW ARM WAS PLACED WITH A NEW TROCAR, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AN ABDOMINAL X-RAY WAS TAKEN OUT OF AN ABUNDANCE OF CAUTION TO GIVE ANOTHER DIAGNOSTIC TOOL TO CONFIRM THAT THERE WAS NOT ANY OTHER METAL IN THE ABDOMEN. THE SURGICAL TASK BEING PERFORMED DURING THE DEVICE BREAKAGE WAS LIFTING THE UTERUS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE ACCESSORY DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT FELL INSIDE THE PATIENT DUE TO AN INSTRUMENT TIP / ACCESSORY COLLISION. THE ACCESSORY WAS NOT REMOVED DURING THE PROCEDURE, PRIOR TO THE BREAKAGE. THE SURGICAL STAFF FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT; IT REMAINED BENT AND UNABLE TO STRAIGHTEN. THERE WAS NO DAMAGE NOTED TO THE CANNULA AFTER THE ACCESSORY WAS REMOVED. THE FRAGMENT WAS RETRIEVED, AND IT WAS CONFIRMED THROUGH EXAMINATION AND LOOKING AROUND THE BELLY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE ACCESSORY IS AVAILABLE FOR RETURN; HOWEVER, A FRAGMENT WAS THROWN AWAY. THERE WERE NO PHOTOGRAPHIC IMAGES OF THE DEVICES OR VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW. NO FURTHER INFORMATION WAS AVAILABLE." }, { "mdr_text_key": "383521892", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO 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": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/02/2025" } ] }