{ "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": "2955842-2020-11281", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201130", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20201023", "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": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20201130", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200625", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1385739", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201130", "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": "M90200626", "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)M90200626", "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": "11/05/2020", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20201130", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20201105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10920414", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201105", "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": "336803475", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1 B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" B2 UPDATED TO \"REQUIRED INTERVENTION\" H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"" }, { "mdr_text_key": "336803476", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "218719921", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(6) HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE MCS TIP COVER ACCESSORY RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY REPORTEDLY FELL INSIDE THE PATIENT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL INSIDE THE PATIENT. ALTHOUGH THERE WAS NO REPORTED INJURY AND THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, UNINTENDED ITEMS FALLING INSIDE THE PATIENT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "218719922", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROTECTIVE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS CLIPPED ONTO THE END OF THE MCS INSTRUMENT, HOWEVER IT DID NOT STAY IN PLACE. THE MCS TIP COVER ACCESSORY FELL IN THE PATIENT'S ANATOMY. THE INCIDENT WAS OBSERVED ON THE SCREEN AND THE MCS TIP COVER ACCESSORY COULD BE RECOVERED. AFTER EXTRACTION, A NEW MCS TIP COVER ACCESSORY WAS USED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY." } ], "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": "05/24/2023" } ] }