{ "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": "2955842-2025-30182", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250723", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250701", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20250723", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240718", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2613159", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250723", "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": "K11240718", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)K11240718", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/11/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250926", "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": "20250723", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "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": "20250702", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22575177", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250702", "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": "375616263", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. PLEASE REFER TO MFR REPORT NUMBER- 2955842-2025-30181 FOR DOCUMENTATION OF THE OTHER TIP COVER THAT FELL DURING THE SAME PROCEDURE." }, { "mdr_text_key": "375616264", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IN THE MATERNITY OPERATING ROOM, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED AND ENDED UP IN THE PATIENT'S INTRAPERITONEAL CAVITY, WHICH THE SURGEON SUBSEQUENTLY REMOVED. THE MCS AND SHEATH WERE REPLACED, BUT THE SECOND MCS TIP COVER ACCESSORY ALSO SLIPPED FROM THE SECOND PAIR, AND IT WAS OBSERVED BY SEVERAL PEOPLE IN THE OPERATING ROOM. UPON VERIFICATION, IT WAS FOUND THAT BOTH SHEATHS HAD THE SAME LOT NUMBER. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY ISSUES DURING USE. THE INCIDENT RESULTED IN PROLONGED SURGERY AND INCREASED STRESS FOR THE SURGEON. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND TIP COVER WERE INSPECTED BEFORE USE, AND THERE WAS NOTHING UNUSUAL NOTED. THE TIP COVER FELL DURING DISSECTION. IT WAS RETRIEVED USING GRASPING FORCEPS AND IT WAS REMOVED THROUGH THE CANNULA WITHOUT DIFFICULTY. THERE WAS NO COLLISION. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY FUNCTIONALITY ISSUES. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED; A FOUR EYES CHECK HAD BEEN PERFORMED TO VERIFY PROPER INSTALLATION. THE ORANGE SURFACE WAS NOT VISIBLE, AND THE TIP COVER STOPPED AT THE EDGE OF THE ORANGE SURFACE WITHOUT GOING BEYOND IT. THE INSTALLATION TOOL WAS USED. THERE WAS NO REDUCER OR LUBRICANT USED. THERE WAS NO DAMAGE TO THE MCS OR CANNULA. THE FIRST TIP COVER REMOVED HAD A SPLIT AT THE DISTAL BLADE SIDE, THOUGH IT WAS UNKNOWN WHETHER IT WAS DAMAGED ON REMOVAL OR PRIOR TO THE EVENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A DELAY OF GREATER THAN 30 MINUTES." }, { "mdr_text_key": "378855357", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "378855358", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "TIP COVER ACCESSORY WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE TIP COVER WAS PLACED ON A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT. THE ACCESSORY WAS TIGHTLY ATTACHED TO THE SCISSOR AND COULD ONLY BE REMOVED WITH CONSIDERABLE EFFORT. THE TIP COVER WAS FOUND TO HAVE SMALL TEARING 15-20MM FROM THE PROXIMAL END WHERE THE INSTRUMENT INSERTS. TEARS ARE NOT AXIALLY ALIGNED WITH THE TIP COVER AND MEASURE FROM 1MM TO 2MM IN LENGTH. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE OTHER TIP COVER WAS ALSO ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. USING A SHEATH, THE TIP COVER WAS PLACED ON A MONOPOLAR CURVED SCISSOR. THE TIP COVER WAS TIGHTLY ATTACHED TO THE SCISSOR AND COULD ONLY BE REMOVED WITH CONSIDERABLE EFFORT. NO PRODUCT ISSUE WAS IDENTIFIED. ADDITIONAL OBSERVATION WAS THAT THE TIP COVER WAS FOUND TO HAVE TEARING IN THE TRANSPARENT PART AT THE MOUTH WHERE THE SCISSOR TIPS EXIT - THE ADJACENT GREY PART DOES NOT SHOW DAMAGE. THE TIP COVER WAS FOUND TO HAVE 3 TEARS 25MM, 40MM AND 45MM FROM THE PROXIMAL END WHERE THE INSTRUMENT INSERTS. TEARS ARE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURE FROM 1MM TO 2MM IN LENGTH. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS." } ], "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": "08/25/2025" } ] }