{ "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": "N", "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": "2955842-2026-19710", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "", "date_received": "20260330", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260303", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260330", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "102298", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260330", "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": "430035-13", "catalog_number": "430035", "lot_number": "NA", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DAY", "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": [ "Detachment of Device or Device Component" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/02/2026;*", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260824", "health_professional": "N", "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": "20260330", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260824", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24722912", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260304", "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": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "396915291", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT #2955842-2026-19709 FOR MDR SUBMISSION OF THE EVENT AGAINST THE MCS INSTRUMENT." }, { "mdr_text_key": "396915292", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, A FRAGMENT FROM THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BROKE OFF. THE MCS TIP ALONG WITH A SMALL PLASTIC PIECE FROM THE INSTRUMENT WAS FOUND AND REMOVED FROM THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PRIOR TO SURGERY, THE MCS INSTRUMENT AND TIP WERE CAREFULLY INSPECTED, AND NO ISSUES OR DAMAGE WERE OBSERVED. DURING THE PROCEDURE, WHICH INVOLVED DISSECTING, A FRAGMENT OF THE INSTRUMENT UNEXPECTEDLY FELL INSIDE THE PATIENT AFTER APPROXIMATELY THREE HOURS OF USE. THE SURGEON WAS UNABLE TO DETERMINE THE CAUSE OF THE INCIDENT, NOTING THAT THERE WERE NO PRIOR FUNCTIONAL ISSUES AND NO COLLISIONS WITH OTHER INSTRUMENTS OR HARD MATERIAL. THE FRAGMENT WAS RETRIEVED AT THE BEDSIDE WITH ALL FRAGMENTS ACCOUNTED FOR AND NO NEED FOR ADDITIONAL PROCEDURES OR POST-OPERATIVE IMAGING. THE SURGICAL PROCEDURE WAS COMPLETED USING A BACKUP MCS INSTRUMENT AND NO PATIENT INJURIES WERE OBSERVED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "400003375", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "400003376", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G5, H2, AND H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO PERFORM FAILURE ANALYSIS EVALUATION. THE MCS INSTRUMENT WAS FOUND TO HAVE A BROKEN 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, MEASURING APPROXIMATELY 1.6MM X 2.3MM IN SIZE, WAS NOT RETURNED WITH THE INSTRUMENT. A VISUAL INSPECTION WAS PERFORMED AND THERE WAS NO DAMAGE TO THE SNAKE WRIST CABLES, HOUSING AND SHAFT. THE INSTRUMENT WAS ALSO FOUND TO HAVE RESIDUE ON ALL FOUR OF THE CLAMPING PULLEYS, LOCATED INSIDE THE BACKEND OF THE INSTRUMENT. ADDITIONALLY, THE HOUSING WAS REMOVED FOR INSPECTION AND ORANGE DISCOLORATION WAS OBSERVED ON A BEARING NEAR THE CLAMPING PULLEY, WHICH INDICATES CORROSION." } ], "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": "04/29/2026;08/24/2026" } ] }