{ "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": "2955842-2025-49437", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251222", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20251201", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20251222", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2474986", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251222", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180", "catalog_number": "400180", "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 Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/02/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260223", "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": "20251222", "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": "20260126", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23865785", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251205", "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": "388269795", "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 MCS TIP COVER ACCESSORY FELL INTO A PATIENT. A FRAGMENT WAS RETIRED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "388269796", "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." }, { "mdr_text_key": "391385191", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: BOTH THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE THOROUGHLY INSPECTED PRIOR TO USE, AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED; THEY APPEARED TO BE IN PROPER CONDITION AT THE START OF THE PROCEDURE. THE EVENT OCCURRED WHILE THE SURGICAL TEAM WAS PERFORMING A DISSECTING TASK. DURING THIS PROCESS, THE MCS TIP COVER ACCESSORY BECAME DISLODGED AND FELL INSIDE THE PATIENT. THE ACCESSORY WAS RETRIEVED WITHOUT COMPLICATIONS USING A COELIO (LAPAROSCOPIC) INSTRUMENT. THE TOTAL DURATION OF USE FOR THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS APPROXIMATELY 2 HOURS, AND AT NO POINT DID THE SURGEON NOTICE ANY FUNCTIONAL ISSUES WITH THE INSTRUMENT - NOR WAS THERE ANY REPORT OF INSTRUMENT COLLISION DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY WAS CAREFULLY INSTALLED ACCORDING TO GUIDELINES: NO PART OF THE ORANGE MARKING WAS VISIBLE, AND THERE WAS NO EVIDENCE OF OVER-INSTALLATION (I.E., THE COVER WAS NOT PLACED BEYOND THE ORANGE SURFACE). THE SURGEON WAS UNABLE TO IDENTIFY A CAUSE FOR THE ACCESSORY¿S DISLODGEMENT, AS INSTALLATION AND HANDLING ALL APPEARED CORRECT. THE USUAL REDUCER WAS USED, AND NO DIFFICULTY WAS REPORTED DURING REMOVAL OF THE INSTRUMENT OR THE ACCESSORY, WITH THE WRIST OF THE INSTRUMENT HAVING BEEN PROPERLY STRAIGHTENED BEFORE REMOVAL. AFTER THE EVENT, THE SURGICAL STAFF NOTED NO DAMAGE TO THE TIP COVER, THE SCISSORS, OR THE CANNULA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY AFTER THE LOST TIP COVER WAS RETRIEVED AND REPLACED, WITHOUT NECESSITY FOR CONVERSION TO OPEN OR TRADITIONAL LAPAROSCOPIC SURGERY. THE MCS TIP COVER ACCESSORY IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION; HOWEVER, THE MCS INSTRUMENT REMAINS IN ACTIVE USE BY THE SURGICAL STAFF AND IS NOT BEING RETURNED, AS IT FUNCTIONED APPROPRIATELY." }, { "mdr_text_key": "391385192", "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": "01/26/2026" } ] }