{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2020-10927", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200918", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200819", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200918", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1018296", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200918", "brand_name": "DA VINCI ACCESSORY", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "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": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250817", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200918", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "113", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20200821", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10552027", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200821", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "207699261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MCS TIP COVER ACCESSORY HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. SYSTEM LOG REVIEW: THE PART #400180 IS AN ACCESSORY AND DOES NOT SHOW IN THE LOGS. THEREFORE, THE ACCESSORY LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MCS INSTRUMENT WAS REMOVED FROM THE PATIENT AND THE TIP COVER ACCESSORY WAS MISSING FROM THE INSTRUMENT. THE SURGICAL STAFF SEARCHED FOR THE MCS TIP COVER ACCESSORY AND PERFORMED BOTH AN X-RAY AND CT SCAN, BUT THE ITEM WAS NOT FOUND. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY AT THE TIME OF THE EVENT, BUT IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS AS A RESULT OF POTENTIALLY RETAINING A FOREIGN OBJECT. THE CAUSE OF THE MCS TIP COVER ACCESSORY BECOMING DISLODGED FROM THE MCS INSTRUMENT COULD NOT BE DETERMINED BECAUSE NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER AND NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. AS OF THE DATE OF THE REPORT, THE LOCATION OF THE MCS TIP COVER ACCESSORY REMAINS UNKNOWN." }, { "mdr_text_key": "207699262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD A VERY LARGE UTERUS WHICH MADE THE CASE VERY DIFFICULT. THE MCS INSTRUMENT WAS DIFFICULT TO REMOVE; THE CUSTOMER FELT TENSION AND IT WAS NOTED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER PERFORMED AN X-RAY PRIOR TO CLOSING THE PATIENT AND THE MCS TIP COVER ACCESSORY WAS NOT IDENTIFIED. A CT SCAN WITHOUT CONTRAST WAS ALSO PERFORMED POST-PROCEDURE. THE MCS TIP COVER ACCESSORY WAS STILL MISSING AND IT WAS NOT CONFIRMED IF IT WAS INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }