{ "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": "2955842-2025-17044", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250429", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250318", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250429", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241017", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1881876", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250429", "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": "K10241017", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250411", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874114374", "udi_public": "(01)10886874114374(17)261031(10)K10241017", "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", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "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": "20250429", "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": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250401", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21930795", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250401", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "369215187", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND THE MCS RETAINING TIP WAS FOUND TO HAVE A CRACKING DAMAGE. NO MATERIAL APPEARS TO BE MISSING. THIS DAMAGE IS TYPICALLY OBSERVED DURING ACCESSORY INSTALLATION WHEN THE RETAINING TIP COVER IS PUSHED OVER THE INSTRUMENT TUBE ADAPTER WITHOUT BEING CORRECTLY ALIGNED, IF THE RETAINING COVER IS TWISTED BEFORE THE ACCESSORY IS FULLY SEATED, OR IF THE RETAINING COVER IS OVER-ROTATED. IF THE RETAINING COVER IS INCORRECTLY ALIGNED AND THE BAYONET DOES NOT ENTER THROUGH THE RETAINING CHANNEL ON THE INSTRUMENT TUBE ADAPTER, THE BAYONETS IN THE RETAINING COVER CAN BE FORCED OUTWARDS AND RESULT IN THE DAMAGE OBSERVED. PROPER ALIGNMENT IS ACHIEVED BY LINING UP THE WHITE STRIPE ON THE INSTRUMENT WITH THE BLACK STRIPE ON THE COVER." }, { "mdr_text_key": "369215188", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP INSTALLED ON AN MCS INSTRUMENT, CAME OFF AND FELL INSIDE THE PATIENT'S BODY. THE CUSTOMER RETRIEVED THE MCS TIP AND TRIED TO PUT IT BACK ON THE MCS INSTRUMENT; HOWEVER, IT DID NOT WORK FOR AN UNSPECIFIED REASON. THEREFORE, THE CUSTOMER REPLACED THE MCS TIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING ABNORMAL WAS NOTED. IT IS UNKNOWN WHAT TASK WAS BE BEING PERFORMED AT THE TIME OF THE EVENT. THE SURGEON STATED THAT THE TIP OF THE MCS INSTRUMENT HAD BECOME STUCK IN THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AND THEN IT WAS FORCIBLY REMOVED, WHICH WAS THE CAUSE OF THE MCS TIP INSIDE THE PATIENT. IT IS UNKNOWN FOR HOW LONG THE INSTRUMENT WAS IN USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE VENT. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. ADDITIONALLY, THE SURGICAL STAFF DID NOT SEE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. IT IS UNKNOWN IF SURGICAL STAFF NOTICED ANY DAMAGE TO THE INSTRUMENT AFTER THE EVENT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE MCS TIP. IT IS UNKNOWN IF ANY POST OPERATIVE TEST LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THERE ARE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS AVAILABLE FOR REVIEW." } ], "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": "" } ] }