{ "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": "2955842-2023-12243", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230428", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20230330", "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": "20230428", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "477555", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230428", "brand_name": "DA VINCI", "generic_name": "DA VINCI INSTRUMENT", "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": "N/A", "catalog_number": "N/A", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20230428", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "44 YR", "patient_sex": "Female", "patient_weight": "105 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions", "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230331", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16829047", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230331", "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": "314160591", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE SURGEON FOUND A \"FOREIGN OBJECT\" INSIDE THE PATIENT. THE OBJECT WAS DESCRIBED AS POSSIBLY BEING A NEEDLE AND THE SURGEON WAS UNCERTAIN HOW THE OBJECT GOT INSIDE THE PATIENT. THERE WERE SEVERAL POSSIBILITIES CONSIDERED BY THE CUSTOMER, BUT NOTHING HAS BEEN DETERMINED TO DEFINITIVELY IDENTIFY THE OBJECT. WHILE CLOSING THE LEFT SIDE OF THE CUFF THE SURGEON NOTED APPROXIMATELY ΒΌ INCH OF A FOREIGN OBJECT, THOUGHT TO BE A NEEDLE STICKING OUT. THE SURGEON PULLED ON THE FOREIGN OBJECT AND WAS ABLE TO MOMENTARILY RETRIEVE THE OBJECT. WHILE ATTEMPTING TO REMOVE THE FOREIGN OBJECT WITH A LAPAROSCOPIC INSTRUMENT THE STAFF LOST THE FOREIGN OBJECT. THE STAFF ATTEMPTED TO VIEW THE OBJECT THROUGH X-RAY BUT WERE UNABLE TO LOCATE THE OBJECT. THE STAFF ORIGINALLY THOUGHT THE FOREIGN OBJECT COULD HAVE BEEN FROM THE DA VINCI INSTRUMENTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THE STAFF RMA THE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER IS UNSURE WHERE THE FRAGMENT CAME FROM. THE CUSTOMER IS UNSURE IF IT IS FROM AN ACCESSORY OR HAS BEEN THERE BEFORE THE SURGERY, PERHAPS FROM AN APPENDECTOMY YEARS AGO. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN ACCESSORY COLLISION. THE FRAGMENT WAS GRASPED BY THE ASSISTANT WITH A NEEDLE DRIVER INSTRUMENT, BUT WHEN ATTEMPTING TO REMOVE IT FROM THE PORT, THE FRAGMENT WAS LOST AND NEVER FOUND. THE SURGEONS SPENT MORE THAN 1 HOUR LOOKING IN THE ABDOMEN, AND DOING AN X-RAY AS WELL, BUT THE FRAGMENT WAS NOT FOUND. THE FRAGMENT WAS NOT RETRIEVED FROM THE PATIENT, IT WAS LOST. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT INJURY, AND THE PATIENT WAS DOING WELL 2 WEEKS POSTOP. THE PATIENT DID NOT RETURN POST PROCEDURE." }, { "mdr_text_key": "314160592", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM BY THE CUSTOMER NOTING THAT A FOREIGN OBJECT WAS FOUND INSIDE THE PATIENT'S ANATOMY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE SURGEON AND STAFF WAS NOT SURE WHERE THE FRAGMENT CAME FROM OR WHETHER IT WAS IN THE PATIENT'S ANATOMY PRIOR TO THE START OF THE SURGICAL PROCEDURE. THIS COMPLAINT IS A REPORTABLE MALFUNCTION AND ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SURGEON FOUND A FRAGMENT INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. AT THIS TIME THE SOURCE OF THE FRAGMENT REMAINS UNKNOWN. IT IS ALSO UNKNOWN IF THE FRAGMENT IS FROM A DA VINCI PRODUCT. THE FRAGMENT WAS NOT RETRIEVED DURING THE SAME PROCEDURE. THE SURGICAL STAFF ATTEMPTED TO REMOVE THE FRAGMENT BUT IT FELL BACK INSIDE THE PATIENT'S ANATOMY AND COULD NOT BE FOUND. THE LOCATION OF THE FRAGMENT REMAINS UNKNOWN." } ], "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": "" } ] }