{ "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": "2955842-2025-09911", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250320", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250202", "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": "408", "date_added": "20250320", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "471505", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250320", "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": "", "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": "IL", "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": "20250320", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Unspecified Tissue Injury", "Foreign Body In Patient", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250226", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21654764", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250226", "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": "366260033", "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. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "366260034", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. A PATIENT HAD UNDERGONE A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WENT GREAT WITHOUT ANY ISSUES. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER THE PROCEDURE. ABOUT A WEEK LATER, THE PATIENT CAME BACK COMPLAINING OF NAUSEA AND VOMITING. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, AND A MCS TIP COVER ACCESSORY WAS IDENTIFIED. THE SURGEON PERFORMED A LAPAROSCOPIC PROCEDURE AND WAS ABLE TO REMOVE THE TIP COVER. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER HAS SPOKEN WITH THE SURGEON ABOUT THIS TO UNDERSTAND MORE. NO ROBOTIC MSC INSTRUMENT WAS USED DURING THIS CASE AS NONE WERE AVAILABLE ON THAT DATE; HOWEVER, PER THE PREFERENCE CARD THE TEAM OPENED A MSC TIP COVER ACCESSORY EXPECTING TO HAVE AN MCS AVAILABLE. THE ONLY ROBOTIC INSTRUMENTS CAPTURED AS HAVING BEEN USED WERE THE PERMANENT CAUTERY HOOK (PCH), CADIERE FORCEPS, LARGE CLIP APPLIER, ENDOSCOPE, AND A GRASPER. LAPAROSCOPIC SCISSORS WERE USED DURING THE CASE. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND NO TECHNICAL ISSUES WERE REPORTED WITH THE ACTUAL SYSTEM. IT WAS UNKNOWN HOW THE MCS TIP COVER ACCESSORY ENDED UP INSIDE OF THE PATIENT. THE MSC TIP COVER DID NOT FIT ON THE LAPAROSCOPIC SCISSORS OR PCH THAT WERE USED DURING THE CASE. NO VIDEO RECORDING WAS AVAILABLE. THE PATIENT WAS STABLE AND THERE WAS NO FURTHER ISSUE. THE SURGEON WAS NOT AWARE HOW THE MCS TIP COVER ENDED UP INSIDE OF THE PATIENT." } ], "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": "" } ] }