{ "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": "2955842-2025-49439", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251223", "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": "20251223", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "445622", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251223", "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": "20260317", "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": "20251223", "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": "20260123", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23878414", "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": "391098251", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: PRIOR TO THE SURGICAL PROCEDURE, BOTH THE INSTRUMENT AND THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WERE INSPECTED ACCORDING TO STANDARD PROTOCOL, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS OBSERVED DURING THIS PRE-USE CHECK. DURING THE OPERATION, THE MCS TIP COVER ACCESSORY ACCIDENTALLY FELL INSIDE THE PATIENT WHILE THE SURGICAL TEAM WAS PERFORMING A DISSECTION TASK. TO RETRIEVE THE ACCESSORY, A COELIO INSTRUMENT WAS USED SUCCESSFULLY. THE SURGEON WAS UNABLE TO IDENTIFY A SPECIFIC CAUSE FOR THE ACCESSORY SLIPPING OFF OR BREAKING. THE MCS INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY TWO HOURS AT THE TIME OF THE EVENT, AND NO FUNCTIONAL ISSUES OR ABNORMAL BEHAVIOR WERE NOTED WITH THE INSTRUMENT THROUGHOUT THE PROCEDURE. REGARDING INTRAOPERATIVE CONDITIONS, THERE WAS NO COLLISION BETWEEN THE MCS INSTRUMENT AND ANY OTHER SURGICAL TOOLS, AND THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED ACCORDING TO THE TEAM¿S VISUAL ASSESSMENT¿SPECIFICALLY, NO PART OF THE ORANGE SURFACE WAS VISIBLE, NOR WAS THE TIP COVER INSTALLED BEYOND THIS SURFACE, AVOIDING ANY BULGING OF THE SHAFT. ADDITIONALLY, THE USUAL REDUCER WAS EMPLOYED, AND REMOVAL OF THE INSTRUMENT AND TIP COVER THROUGH THE CANNULA WAS CONDUCTED WITHOUT RESISTANCE OR DIFFICULTY. THE INSTRUMENT WRIST WAS STRAIGHTENED PRIOR TO REMOVAL, PER RECOMMENDED PRACTICE, TO REDUCE THE RISK OF DAMAGE OR COMPLICATIONS. FOLLOWING THE TIP COVER INCIDENT, THE SURGICAL STAFF DETECTED NO OTHER DAMAGE ON THE MCS TIP COVER ACCESSORY, THE INSTRUMENT ITSELF, OR THE CANNULA. TO RESOLVE THE SITUATION, THE TIP COVER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED WITHOUT THE NEED TO CONVERT TO AN ALTERNATIVE SURGICAL APPROACH OR ABORT THE OPERATION. THE MCS TIP COVER ACCESSORY INVOLVED IN THE EVENT IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL (ISI) FOR EVALUATION, WHILE THE MCS INSTRUMENT, WHICH CONTINUED TO FUNCTION CORRECTLY, REMAINS IN USE AND IS NOT SLATED FOR RETURN." }, { "mdr_text_key": "391098252", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "388379421", "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": "388379422", "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." } ], "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": "01/23/2026" } ] }