{ "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": "2955842-2025-35515", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250825", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250801", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250825", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1351868", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250825", "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", "catalog_number": "400180", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/25/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251104", "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": "20250825", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20250801", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22882858", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250801", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "378415385", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "378415386", "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 SLID OFF. THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED TECHNICAL SUPPORT TO REPORT THAT THE MCS TIP COVER WAS SLIDING UPWARDS WHEN REMOVING THE INSTRUMENT. THE CSR ASKED IF THE MCS TIP COVER WOULD SHOW UP ON X-RAY. THE TECHNICAL SERVICE ENGINEER (TSE) INFORMED THE CSR THAT THE MCS TIP COVER IS RADIOLUCENT. THE TSE RECOMMENDED THE SITE CALL BACK IN IF THEY REQUIRE ADDITIONAL ASSISTANCE OR HAVE ANY FURTHER INFORMATION TO PROVIDE. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "384253873", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 25-AUG-2025, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: TECHNICIAN SAID SHE DID NOT INSPECT THE INSTRUMENT, BUT IT WENT ON EASY, WHICH LED HER TO BELIEVE THAT THERE MIGHT HAVE BEEN DAMAGE TO IT WHEN SHE WAS PLACING IT ON THE SCISSORS. THE MCS TIP COVER SLID OFF THE INSTRUMENT UPON REMOVAL AND THE CANNULA WAS NOT FULLY IN PLACE, SO IT WAS STUCK AT THE PORT SITE, BUT ONCE THE STAFF VISUALIZED IT, THEY WERE ABLE TO RETRIEVE IT. THE CUSTOMER BELIEVED THAT THE CAUSE OF THE MCS TIP COVER FALLING OF THE INSTRUMENT WAS RELATED TO A BREAK IN THE TIP COVER ACCESSORY. THE INSTRUMENT WAS IN USE FOR ABOUT 1.5 - 2 HOURS. THE SURGEON DIDN'T NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. IT WAS NOTED THAT MCS TIP COVER ACCESSORY WAS NOT PROPERLY INSTALLED ONLY FOR A PORTION OF THE PROCEDURE AND WHEN THE CUSTOMER REMOVED THE INSTRUMENT TO CHANGE IT. THE TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. AN INSTALLATION TOOL WAS NOT USED. AN ELECTROLUBE, OR OTHER LUBRICANT WAS NOT APPLIED TO THE MCS INSTRUMENT PRIOR TO THE TIP COVER ACCESSORY INSTALLATION. THERE WAS NO REDUCER USED. THE CUSTOMER HAD TROUBLE REMOVING THE INSTRUMENT WITH THE MCS TIP COVER ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE MCS TIP COVER ACCESSORY AND THE MCS INSTRUMENT ARE NOT AVAILABLE FOR RETURN. THE CSR WAS NOT SURE IF PHOTOGRAPHIC IMAGES OF THE DEVICE, OR A VIDEO RECORDING OF THE PROCEDURE ARE AVAILABLE FOR ISI REVIEW." }, { "mdr_text_key": "384253874", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "09/12/2025" } ] }