{ "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": "2955842-2024-10195", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240117", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20231220", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240117", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1773518", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240117", "brand_name": "DA VINCI", "generic_name": "SEAL", "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": "470500-13", "catalog_number": "470500", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20240117", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231220", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18527684", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231220", "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": "333049632", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED FOR RETURN OF THE UNIVERSAL SEAL FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE SEAL HAS NOT BEEN RECEIVED. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "333049634", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE SCRUB TECH NOTICED WHILE LOOKING INSIDE OF THE PELVIS OF THE PATIENT THAT A BLACK PIECE OF THE RUBBER PART OF THE UNIVERSAL SEAL FELL OFF INTO THE PATIENT. A GRASPER WAS UTILIZED TO REMOVE THE FRAGMENT FROM THE PATIENT. NO FRAGMENT WAS LEFT BEHIND INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO NOTED DAMAGE PRIOR TO USE OF THE CANNULA SEAL. THE SURGEON WAS UNSURE WHEN THE FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, THE SURGEON SUSPECTED IT MAY HAVE BEEN OCCURRED WHEN INSERTING AN INSTRUMENT ONTO AN ARM AND THROUGH THE CAP OF THE CANNULA SEAL. THE PROCEDURE HAD BEEN IN PROGRESS FOR APPROXIMATELY 45 MINUTES WHEN THE EVENT OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. IT WAS REPORTED THAT AN INSTRUMENT DID NOT BREAK. THE CANNULA SEAL WAS REMOVED AND REPLACED. THE AREA OF CANNULA SEAL WAS NOTED TO BE DAMAGED WHERE THE PIECE HAD BROKEN OFF. THE FIRST ASSIST USED A GRASPER TO RETRIEVE THE PIECE AND REMOVE IT FROM THE PATIENT. ALL THE FRAGMENTS WERE RETRIEVED. THERE WERE NO ADDITIONAL SURGICAL PROCEDURE DONE TO REMOVE THE FRAGMENT. THERE WERE NOT ANY POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT DID NOT RETURN TO THE HOSPITAL." } ], "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": "" } ] }