{ "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": "2955842-2025-28492", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250708", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250612", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20250708", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240711", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2435543", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250708", "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": "K11240711", "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)K11240711", "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", "Material Split, Cut or Torn", "Detachment of Device or Device Component", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/20/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251113", "health_professional": "Y", "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": "20250708", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "49 YR", "patient_sex": "Female", "patient_weight": "93 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250613", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22440813", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250613", "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": "383026574", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE TIP COVER ACCESSORY WAS RECEIVED FOR FAILURE ANALYSIS. THE REPORTED EVENT WITH THE ACCESSORY COULD NOT BE REPLICATED NOR CONFIRMED. USING A SHEATH, THE TIP COVER WAS PLACED ON A MONOPOLAR CURVED SCISSOR INSTRUMENT. THE TIP COVER WAS TIGHTLY ATTACHED TO THE SCISSOR AND COULD ONLY BE REMOVED WITH CONSIDERABLE EFFORT. THE TIP COVER WAS FOUND TO HAVE TEARING AT THE MOUTH WHERE THE SCISSOR TIPS EXIT. THE TEARS WERE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED FROM 3.0 MM TO 5.0 MM IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE." }, { "mdr_text_key": "383026575", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "374375761", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF THE INSTRUMENT DURING THE OPERATION AND FELL INTO THE PATIENT'S ABDOMEN. BOTH THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED, AND NO DAMAGE OR UNUSUAL FINDINGS WERE REPORTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING THE RECOMMENDED METHOD, INVOLVING STERILE REMOVAL FROM ITS PACKAGING AND ATTACHMENT TO THE SCISSORS WITH THE BLUE COATING AID. DURING THE PROCEDURE, THE SURGICAL TEAM WAS UNABLE TO IMMEDIATELY IDENTIFY WHEN THE TIP COVER FELL INSIDE THE PATIENT, AND THUS, THEY COULD NOT SPECIFY THE SURGICAL TASK BEING PERFORMED AT THAT TIME. THE SURGEON DID NOT OBSERVE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE APPROXIMATELY TWO-HOUR USE, NOR DID THE INSTRUMENT COLLIDE WITH ANY OTHER INSTRUMENTS. THE ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO VISIBLE ORANGE SURFACE, AND THE INSTALLATION TOOL WAS UTILIZED. NO LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLATION, AND NO REDUCER WAS USED. THE REMOVAL OF THE INSTRUMENT AND ACCESSORY WAS STRAIGHTFORWARD, WITH THE WRIST STRAIGHTENED UPON EXTRACTION. AFTER THE EVENT, THE SURGICAL STAFF NOTICED THAT THE TIP COVER WAS TORN ON BOTH SIDES OF THE INSTRUMENT MOUTH. THE PROCEDURE WAS COMPLETED WITH ROBOT-ASSISTED CLOSURE, ALTHOUGH NO PHOTOGRAPHIC OR VIDEO DOCUMENTATION OF THE DEVICES OR PROCEDURE IS AVAILABLE FOR REVIEW BY INTUITIVE SURGICAL, INC. (ISI)." }, { "mdr_text_key": "374375762", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS." } ], "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": "08/27/2025" } ] }