{ "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": "2955842-2023-18100", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230830", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20230803", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230830", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230209", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1397166", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230830", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "L81230209", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)L81230209", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/11/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20230830", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230803", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17654629", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230803", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "322328919", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT. THE CUSTOMER REMOVED THE SHEATH FROM THE PATIENT. THE MCS TIP COVER WAS THROWN OUT AND WILL NOT BE RETURNED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "322328924", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS INVESTIGATIONS. A RETURN MATERIAL AUTHORIZATION (RMA) WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE ACCESSORY WAS DISPOSED. THE CUSTOMER REMOVED THE SHEATH FROM THE PATIENT. THE TIP COVER WAS THROWN OUT AND WILL NOT BE RETURNED. ALTHOUGH THE COMPLAINT REGARDING THE MCS TIP ACCESSORY FALLING OFF WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE ACCESSORY WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, FAILURE ANALYSIS INVESTIGATION OF THE PRODUCT FOR A PROBABLE CAUSE COULD NOT BE PERFORMED, AND THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED." }, { "mdr_text_key": "337996957", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "337996958", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 10/11/2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAD REGULAR INSPECTION PRIOR TO USE, AND NOTHING WAS NOTICED. THE MCS TIP COVER ACCESSORY RETRIEVED BY GRABBING IT WITH THE OTHER ARM. THE CUSTOMER WAS UNSURE OF WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY DID APPEAR TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE REDUCER WAS NOT USED. THE INSTRUMENT WRIST STRAIGHTENED UPON REMOVAL CONTACT PERSON STATED IT WAS NOT APPLICABLE AS THEY DON¿T KNOW WHEN IT CAME OFF. THE PROCEDURE COMPLETED ROBOTICALLY. THE MCS INSTRUMENT IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION. THE INFORMATION REGARDING PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW WHEN THEY CONTACTED IN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/19/2023" } ] }