{ "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": "2955842-2023-21478", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20231227", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20231128", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231227", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1610881", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231227", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "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": "", "device_evaluated_by_manufacturer": "R", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20231227", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231128", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18401003", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231128", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "331425244", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. THEREFORE THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS USED IN A SUBSEQUENT SURGICAL PROCEDURE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DID NOT REVEAL ANY RELATED COMPLAINT(S) TO THE MCS INSTRUMENT. ." }, { "mdr_text_key": "331425245", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE CASE, THE CUSTOMER HABITUALLY INCLUDES THE TIP COVER ACCESSORY IN THE INTRAOPERATIVE COUNTS, BUT DID NOT REALIZE THE COUNT WAS INCORRECT UNTIL AFTER THE PATIENT WAS CLOSED. THE PATIENT REMAINED IN THE OPERATING ROOM AND UNDER ANESTHESIA THROUGHOUT THE EVENT. THE STAFF SPENT ROUGHLY 20 MINUTES SEARCHING THE OR FOR THE MISSING TIP COVER ACCESSORY BEFORE THE SURGEON REOPENED THE PATIENT. A 12MM AND TWO 5MM PORTS WERE USED DURING REENTRY, AND THE TIP COVER ACCESSORY WAS FOUND WITHIN A COUPLE OF MINUTES OF MANIPULATING THE BOWEL. ONCE RETRIEVED, THE CSR INSPECTED THE TIP COVER ACCESSORY AND THERE WAS NO DAMAGE NOTED. ADDITIONALLY, THERE WERE NO ISSUES WITH THE INSTALLATION OF THE TIP COVER ACCESSORY AND NO LUBRICATION WAS USED. DURING THE PROCEDURE, THE CUSTOMER DID NOT EXPERIENCE ANY ISSUES WITH THE INSTRUMENT. THERE WAS NO BULGING OF THE TIP COVER ACCESSORY OBSERVED ON THE MCS INSTRUMENT. ADDITIONALLY, NO ORANGE WAS SHOWING ON THE SHAFT OF THE MCS INSTRUMENT WHICH INDICATES THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED. THE SURGICAL TECHNOLOGIST HAD REPORTEDLY NOTICED THE TIP COVER ACCESSORY WAS NOT ON THE MCS INSTRUMENT WHEN HE REMOVED THE INSTRUMENT AT THE END OF THE CASE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }