{ "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": "2955842-2025-45729", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251120", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20251015", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20251120", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250501", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1034269", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251120", "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": "K12250501", "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)K12250501", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/03/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260310", "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": "20251120", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251230", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23606902", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251027", "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": "385648274", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SEAL ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "385648577", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, RUBBER PARTS WERE DAMAGED AND FELL OFF THE CANNULA UNIVERSAL SEAL ACCESSORY. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE FOUND. DURING THE PROCEDURE, A FRAGMENT FROM THE DEVICE FELL INSIDE THE PATIENT WHILE THE INSTRUMENT WAS BEING INSERTED OR REMOVED. THE SURGEON DID NOT PROVIDE A SPECIFIC CAUSE FOR THE BREAKAGE; IT WAS ONLY NOTICED WHEN THE INCIDENT OCCURRED, WITH NO PRIOR SIGNS. THE ACCESSORY HAD BEEN USED FOR APPROXIMATELY 120 MINUTES BEFORE THE ISSUE AROSE, AND NO FUNCTIONAL ISSUES WERE OBSERVED DURING THE PROCEDURE. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS. THE FRAGMENT FELL DURING AN INSTRUMENT TIP/ACCESSORY COLLISION DURING INSTRUMENT MANIPULATION. AN INSTRUMENT WAS REMOVED PRIOR TO BREAKAGE WITH THE WRIST STRAIGHTENED, AND NO RESISTANCE WAS FELT DURING REMOVAL THROUGH THE CANNULA. THE FRAGMENT WAS RETRIEVED USING LAPAROSCOPIC FORCEPS, AND ALL PIECES WERE CONFIRMED AS REMOVED BY MATCHING THEM TO THE BROKEN AREA. NO ADDITIONAL SURGICAL PROCEDURES WERE NEEDED. A POST-OPERATIVE X-RAY WAS PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, WITH NO ADDITIONAL INJURY TO THE PATIENT AND NO POST-SURGICAL COMPLICATIONS OR HOSPITAL READMISSIONS RELATED TO RETAINED FOREIGN OBJECTS. THE INSTRUMENT, ACCESSORY, AND RETRIEVED FRAGMENT WILL ALL BE RETURNED TO ISI FOR EVALUATION, BUT NO PHOTOGRAPHIC IMAGES OR PROCEDURAL VIDEO WERE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "390683325", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: THE UNIVERSAL SEAL WAS ANALYZED AND FOUND TO HAVE A TEAR ON THE BLACK RUBBER DUCKBILL. THE TORN PIECE WAS MISSING AND WAS NOT RETURNED WITH THE SEAL." }, { "mdr_text_key": "390683326", "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": "12/30/2025" } ] }