{ "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": "2955842-2026-16776", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20260323", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260226", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20260323", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "723852", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260323", "brand_name": "DA VINCI", "generic_name": "MONOPOLAR CURVED SCISSORS (MCS) TIP", "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": "430035", "catalog_number": "430035", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "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": [ "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/24/2026;03/30/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260527", "health_professional": "Y", "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": "20260323", "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" ] } ], "distributor_city": "", "date_report": "20260421", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24669816", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260226", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "396540439", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "396540440", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION: A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER WAS PERFORMED. THE IMAGE EXHIBITS AN SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH A BROKEN INSTRUMENT TUBE ADAPTER." }, { "mdr_text_key": "399588486", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G6, H2, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE MONOPOLAR CURVED SCISSORS (MCS) TIP ACCESSORY FOR FAILURE ANALYSIS EVALUATION. HOWEVER, ISI RECEIVED THE MCS INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE MCS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN INSTRUMENT TUBE ADAPTER. THIS COMPONENT IS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND SERVES AS THE INTERFACE BETWEEN THE INSTRUMENT AND THE USER-INSTALLED TIP ACCESSORY. THE BROKEN PIECE WAS NOT RETURNED AND MEASURES APPROXIMATELY 0.57 MM X 1.49 MM IN SIZE. AN IN-HOUSE MCS TIP ACCESSORY WAS SUCCESSFULLY INSTALLED DESPITE THE DAMAGE. MANUAL TIP ARTICULATION WAS PERFORMED AND PASSED. THE GRIP OPENED AND CLOSED PROPERLY WHEN THE GRIP KNOB WAS MANUALLY ROTATED. THE INSTRUMENT WAS PLACED ON THE IN-HOUSE SYSTEM FOR TESTING AND PASSED ENERGY DELIVERY. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE HOUSING WAS REMOVED, AND THERE WAS NO DAMAGE FOUND. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER COMPLAINT WAS THAT THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE DETACHED FRAGMENT WAS FROM THE BROKEN INSTRUMENT TUBE ADAPTER BUT NOT RETURNED. THE DETACHED FRAGMENT MEASURES APPROXIMATELY 0.57 MM X 1.49 MM." }, { "mdr_text_key": "399588487", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "396340179", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE PORT (SP) DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP FELL INSIDE OF THE PATIENT DUE TO A BROKEN JOINT. IT WAS UNKNOWN IF ALL FRAGMENTS WERE RETRIEVED DUE TO THE SMALL SIZE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT, INSPECTED PRIOR TO USE AND FOUND TO BE UNDAMAGED, WAS IN USE FOR APPROXIMATELY 20 MINUTES WHEN A FRAGMENT FELL INSIDE THE PATIENT DURING INSTRUMENT REMOVAL. THE CAUSE OF THE BREAKAGE IS UNKNOWN, AND THERE WERE NO NOTICEABLE FUNCTIONAL ISSUES OR RESISTANCE UPON REMOVAL. THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED DURING FINAL REMOVAL, WITH NO OBSERVED DAMAGE TO THE CANNULA OR INSTRUMENT. THE FRAGMENT WAS NOT RETRIEVED AS THEY COULD NOT FIND THE FRAGMENT DUE TO IT BEING TOO SMALL. NO POST-OPERATIVE IMAGING WAS PERFORMED. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED, THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THERE WERE NO POST-SURGICAL COMPLICATIONS REPORTED. THE INSTRUMENT WILL BE RETURNED FOR EVALUATION, BUT IT IS UNCLEAR IF THE FRAGMENT WILL ALSO BE RETURNED." }, { "mdr_text_key": "396340180", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP/INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." } ], "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;04/21/2026" } ] }