{ "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": "2955842-2026-03012", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260207", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260112", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260208", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251014", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "346654", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260207", "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": "400180-16", "catalog_number": "400180", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260203", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "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" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260331", "health_professional": "Y", "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": "20260207", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "55 YR", "patient_sex": "Male", "patient_weight": "98 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260207", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24286094", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260113", "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": "392427048", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. DURING THE CASE, WHILE THE SURGEON WAS DISSECTING AND CUTTING TISSUE, IT WAS OBSERVED THAT THE MCS TIP COVER ACCESSORY BEGAN TO SLIDE DOWN OVER THE TIP OF THE MCS INSTRUMENT. THE SURGEON ATTRIBUTED THE DETACHMENT OF THE MCS TIP COVER ACCESSORY TO POSSIBLY USING TOO MUCH LUBRICANT. UPON NOTICING THE ISSUE, THE SURGICAL TEAM ATTEMPTED TO REMOVE THE INSTRUMENT; HOWEVER, THE MCS TIP COVER ACCESSORY BECAME STUCK IN THE TROCAR. THE MCS TIP COVER ACCESSORY WAS THEN SUCCESSFULLY RETRIEVED WITH A GRASPER FROM THE TROCAR WITHOUT THE NEED FOR ANY ADDITIONAL SURGICAL PROCEDURE, SUCH AS LAPAROSCOPY OR AN OPEN SURGERY. THERE WAS NO INJURY TO THE PATIENT CAUSED BY THIS INTRAOPERATIVE EVENT, NOR WAS THERE A NEED FOR ANY POST-OPERATIVE DIAGNOSTIC IMAGING SUCH AS X-RAYS OR ULTRASOUNDS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE USE OF A BACKUP MCS TIP COVER ACCESSORY AFTER THE INITIAL ONE WAS REMOVED. FOLLOWING THE SURGERY, THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "392427049", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY WAS RECEIVED FOR FAILURE ANALYSIS. A VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE MCS TIP COVER ACCESSORY WAS PLACED ON AN IN-HOUSE MCS INSTRUMENT. THE INSTRUMENT WAS THEN PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE MCS TIP COVER ACCESSORY REMAINED TIGHTLY IN PLACE AND DID NOT FALL OFF. THE MCS TIP COVER ACCESSORY FIT COMPLETELY ON THE MCS INSTRUMENT, COVERING THE ORANGE TUBE EXTENSION. THERE WAS NO BULGE AT THE PROXIMAL END OF THE FIT. NO PRODUCT ISSUE WAS IDENTIFIED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }