{ "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": "2955842-2025-29554", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250715", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250616", "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": "408", "date_added": "20250715", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250213", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1169070", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250715", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "470500-13", "catalog_number": "470500", "lot_number": "K11250213", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874116408", "udi_public": "(01)10886874116408(10)K11250213", "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": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/12/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251128", "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": "20250715", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "32 YR", "patient_sex": "Female", "patient_weight": "99 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250618", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22505906", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250618", "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": "374915836", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SEAL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED THE IMAGES PROVIDED SHOWED TWO UNIVERSAL SEALS WITH TORN DUCKBILL COMPONENTS. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT #2955842-2025-29555 FOR MDR SUBMISSION INVOLVING A SIMILAR BUT DIFFERENT EVENT INVOLVING ANOTHER UNIVERSAL SEAL AND A FRAGMENT FALLING INSIDE THE PATIENT THAT WAS ALSO RETRIEVED. SECTION A ADDITIONAL PATIENT INFORMATION: BODY MASS INDEX (BMI) 34.25 KG/M2 WITH A HEIGHT OF 5¿7¿." }, { "mdr_text_key": "374915837", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, A PORTION OF THE BLACK RUBBER ON THE TROCAR CAPS BROKE OFF AND FELL INSIDE OF THE PATIENT. THE UNIVERSAL SEAL WAS IDENTIFIED WHEN THE SURGICAL TEAM NOTICED A DEVICE FRAGMENT IN THE PELVIS. THE CAUSE OF THE FRAGMENT'S DETACHMENT REMAINS UNKNOWN. THE FRAGMENT WAS RETRIEVED BY THE SURGICAL ASSISTANT USING A LAPAROSCOPIC GRASPER, AND ITS RETRIEVAL WAS CONFIRMED BY MATCHING IT TO THE INNER CAP SEAL. NO ADDITIONAL SURGICAL PROCEDURE WAS NEEDED FOR THE REMOVAL OF THE FRAGMENT, AND NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT THE USE OF A BACKUP INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "384262328", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A TOTAL OF 4 DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS UNDER THIS RECORD. THE 4 UNIVERSAL SEALS WERE ANALYZED BY THE FAILURE ANALYSIS (FA) TEAM BUT ONLY 1 OF THEM EXHIBITED THE REPORTED CONDITION. THE UNIVERSAL SEAL #1 WAS FOUND TO HAVE A PIECE OF THE BLACK RUBBER DUCKBILL TORN. THE TORN PIECE WAS NOT RETURNED WITH THE SEAL. THE UNIVERSAL SEAL #2 WAS ANALYZED BUT THE REPORTED ISSUE COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION FOUND NO DAMAGE TO THE SEAL. THE DUCKBILL WAS INTACT, AND THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO PROBLEM DETECTED. THE UNIVERSAL SEAL #3 WAS ANALYZED BUT THE REPORTED ISSUE COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION FOUND NO DAMAGE TO THE SEAL. THE DUCKBILL WAS INTACT, AND THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO PROBLEM DETECTED. THE UNIVERSAL SEAL #4 WAS ANALYZED BUT THE REPORTED ISSUE COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION FOUND NO DAMAGE TO THE SEAL. THE DUCKBILL WAS INTACT, AND THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO PROBLEM DETECTED." }, { "mdr_text_key": "384262329", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "09/11/2025" } ] }