{ "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": "2955842-2022-10235", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220213", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20220118", "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": "20220213", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1182580", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220213", "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": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20220213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20220118", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13519322", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220118", "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": "289439691", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) STATED THE CUSTOMER LOST THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CSR WANTED TO KNOW IF THE MCS TIP COVER ACCESSORY WAS DETECTABLE BY X-RAY. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) INFORMED CALLER THAT THE MCS TIP COVER ACCESSORY WAS RADIOLUCENT AND THUS CANNOT BE DETECTED BY X-RAY. THE CSR STATED THAT NO INJURY WAS REPORTED AND THAT THE SYSTEM WAS FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED AS PLANNED. ON 31-JAN-2022, ISI OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. BOTH THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE USE AND NOTHING LOOKED OUT OF THE ORDINARY. THERE WAS NO DAMAGE ON EITHER ITEM. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT. A REDUCER WAS NOT USED FOR THIS INSTRUMENT. THE MCS TIP COVER ACCESSORY FELL OFF WHEN THEY WERE REMOVING THE INSTRUMENT, BUT THEY DID NOT FEEL ANY RESISTANCE WHEN IT WAS BEING REMOVED. SHE WAS NOT SURE IF THE MCS INSTRUMENT WRIST WAS STRAIGHTENED COMPLETELY UPON REMOVAL. THERE WAS NO DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT OR THE CANNULA AFTER THE ISSUE. THE INSTRUMENT WAS USED FOR AN ESTIMATE OF 1 TO MAYBE 2 HOURS AT THE MOST AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE MCS TIP COVER ACCESSORY WAS INSTALLED CORRECTLY AND THERE WAS NO ORANGE SURFACE VISIBLE AFTER IT WAS INSTALLED ON THE INSTRUMENT. SHE SAID THE INSTALLATION TOOL WAS USED AND NO ELECTROLUBE OR ANY OTHER LUBRICANT WAS APPLIED TO THE INSTRUMENT. THE MCS TIP COVER ACCESSORY WAS DISCARDED AT THE END OF THE PROCEDURE AND THEY ARE STILL USING THE MCS INSTRUMENT." }, { "mdr_text_key": "289439692", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) WILL NOT BE RECEIVING THE MCS TIP COVER ACCESSORY AS IT WAS DISCARDED BY THE SITE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. INFORMATION FOR THE MCS TIP COVER ACCESSORY DOES NOT GET CAPTURED IN THE LOGS, SO NO LOG REVIEWS WERE AVAILABLE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR VIDEO FOR THE EVENT WAS AVAILABLE FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A NEPHRECTOMY PROCEDURE THE MCS TIP COVER ACCESSORY CAME OFF OF THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE MCS TIP COVER ACCESSORY IN THE SAME PROCEDURE. THERE WAS NO INJURY TO THE PATIENT REPORTED, HOWEVER, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION, CONTRIBUTING TO AN ADVERSE EVENT." } ], "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": "" } ] }