{ "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": "2955842-2024-18352", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240821", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20240720", "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": "IN", "manufacturer_contact_area_code": "408", "date_added": "20240821", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221124", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "992135", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240821", "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": "400180-14", "catalog_number": "400180", "lot_number": "L81221124 00", "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": "10886874111045", "udi_public": "(01)10886874111045(10)L81221124", "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": "20250820", "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": "20240821", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20014323", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240721", "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": "349714225", "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. A RETURN MATERIAL AUTHORIZATION (RMA) WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS DISPOSED. ." }, { "mdr_text_key": "349714226", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THE EDGES OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT UNIFORM. IT WAS NOT FITTING PROPERLY TO THE MCS INSTRUMENT. THE CUSTOMER STATED THIS IS A DISPOSABLE ACCESSORY AND CANNOT BE RETURNED. THE HOSPITAL HAS DISCARDED THE ACCESSORY. INTUITIVE SURGICAL, INC. FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY HAD NON-UNIFORM EDGES AS VALIDATED BY THE OPERATING ROOM (OR) TEAM ONCE IT WAS OPEN FROM THE PACK. THE MCS TIP COVER ACCESSORY ALSO DID NOT FIT PROPERLY TO THE MCS, AND THE ORANGE BAND WAS PARTLY VISIBLE. THE TEAM DECIDED TO GO FORWARD WITH THE SAME MCS TIP COVER ASSUMING IT WOULD NOT DETACH FROM THE MCS. HOWEVER, THE SURGEON AND THE OR TEAM WERE QUICK TO VISUALIZE THE IMPROPER ATTACHMENT OF THE MSC TIP COVER ACCESSORY AND CHANGED IT ONCE THE DAMAGE WAS VISUALIZED AND CONFIRMED. THE DAMAGED MCS TIP COVER ACCESSORY DID FALL DURING THE SURGERY, BUT THE SURGICAL TEAM WAS VIGILANT ENOUGH TO IDENTIFY THE IMPROPER ATTACHMENT DUE TO A DEFECT IN THE MCS TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING A LAPAROSCOPIC INSTRUMENT FROM THE ASSISTANT PORT." } ], "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": "" } ] }