{ "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": "2955842-2025-29552", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250714", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241018", "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", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20250714", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "755782", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250714", "brand_name": "DA VINCI", "generic_name": "ENDOWIRST", "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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/01/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250813", "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": "20250714", "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": [ "Foreign Body In Patient", "Unspecified Tissue Injury", "Foreign Body In Patient", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250618", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22494897", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250618", "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": "374825672", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, THE PATIENT CALLED TO REPORT CONTINUED PAIN. THE PATIENT WENT TO ANOTHER HOSPITAL NEARBY AND AN X-RAY WAS PERFORMED. THROUGH THE X-RAY, A FRAGMENT INSIDE OF THE PATIENT WAS FOUND. THE FRAGMENT WAS RETRIEVED THROUGH THE ADDITIONAL SURGERY AT ANOTHER HOSPITAL. THE PATIENT WAS CALLING TO INVESTIGATE WHAT THE FRAGMENT WAS AND WHETHER THE FRAGMENT WAS TOXIC. THE PATIENT WOULD LIKE TO KNOW IF THE FRAGMENT HAD FALLEN FROM AN INTUITIVE INSTRUMENT OR NOT. THE PATIENT SENT PHOTOS OF THE FRAGMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HOSPITAL IS AWARE OF THE ALLEGATION FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS AN INVESTIGATION ALLEGATION. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE HOSPITAL, AND THEY STATED THAT THERE WERE NO ISSUES DURING THE PROCEDURE AT THE TIME. IT IS UNKNOWN WHERE THE PIECE CAME FROM; THE PATIENT SUSPECTS THAT THE FRAGMENT CAME FROM A DA VINCI INSTRUMENT." }, { "mdr_text_key": "374825673", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE INSTRUMENT/ACCESSORY IS UNKNOWN. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED. THE FRAGMENT ON THE PICTURE LOOKED SOMEWHAT SIMILAR TO PART OF THE MEGA NEEDLE DRIVER OR MEGA SUTURECUT NEEDLE DRIVER GRIP, BUT THOSE GRIPS HAVE CARBIDE INSERTS, WHICH THIS FRAGMENT DOES NOT APPEAR TO HAVE, AS THE FRONT AND REAR SURFACES IN THE PROVIDED IMAGES APPEAR SMOOTH." }, { "mdr_text_key": "377538091", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "LOGS WERE REVIEWED BASED ON THE EVENT INFORMATION PROVIDED BY THE CUSTOMER, THE PROVIDED IMAGES DO NOT ALIGN WITH AN INTUITIVE INSTRUMENT SHOWN TO HAVE BEEN USED FOR THE REPORTED PROCEDURE. IF THIS HOSPITAL NAME AND EVENT DATE IS CORRECT PROVIDED BY THE CUSTOMER, THE EVIDENCE DOES NOT SUPPORT THAT AN INTUITIVE INSTRUMENT WOULD HAVE GENERATED THE FRAGMENT SHOWN IN THE PROVIDED IMAGES. THE HOSPITAL IS AWARE OF THE ALLEGATION AND IT IS NOT POSSIBLE TO KNOW FOR SURE IF THE ALLEGATION IS TRUE AND INVESTIGATE. THERE WERE NO ISSUES DURING THE PROCEDURE AT THAT TIME. IT IS UNKNOWN WHERE THE FRAGMENT CAME FROM AS THE PATIENT SUSPECTS FRAGMENT CAME FROM A DA VINCI INSTRUMENT." }, { "mdr_text_key": "377538092", "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": "07/23/2025" } ] }