{ "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": "2955842-2025-06860", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250312", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250214", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250312", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240905", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1663106", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250312", "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": "K11240905", "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": "", "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 Split, Cut or Torn", "Material Fragmentation", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/24/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250312", "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": "20250217", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21587016", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250217", "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": "367814269", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SEAL WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE TEARING AT THE DUCKBILL. THE TEARS WERE NOT AXIALLY ALIGNED WITH THE SEAL AND MEASURED FROM 0.232¿ TO 0.160¿ IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. A REVIEW OF DVSTREAM EVENTS WAS PERFORMED BY AN INTUITIVE QUALITY ENGINEER, INDICATING THAT A CANNULA WAS REMOVED FROM UNIVERSAL SURGICAL MANIPULATOR 3 (USM3) AT TWO POINTS ROUGHLY 3 HOURS INTO THE PROCEDURE. DURING THIS FIRST CANNULA REMOVAL, A VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS INSTALLED ON USM3 AND WAS REMOVED AND RESEATED ALONGSIDE THE USM3 CANNULA. THE SECOND CANNULA REMOVAL WAS FOLLOWED BY A RESEATING OF THE CANNULA WITH A SUREFORM 45 STAPLER INSTALLED. ALL INSTRUMENTS AND CANNULAS WERE REMOVED ROUGHLY 16 MINUTES AFTER THE SECOND MID-PROCEDURE CANNULA REMOVAL/RESEATING." }, { "mdr_text_key": "367814270", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "365598597", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. THE EVENT INVESTIGATION IS IN PROGRESS." }, { "mdr_text_key": "365598598", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, WHEN THE FORCEPS WERE REPLACED, A BLACK SOFT SUBSTANCE ADHERED TO THE FORCEPS. THE SURGEON TOUCHED THE CANNULA SEAL TO CHECK IT BUT COULDN'T JUDGE WHETHER A PART OF THE CANNULA SEAL WAS MISSING. THE FRAGMENT HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED WITH AN UNKNOWN INSTRUMENT. IT WAS CONFIRMED ALL FRAGMENTS WERE RETRIEVED UNDER ENDOSCOPIC OBSERVATION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING THE SAME CANNULA. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." } ], "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": "04/08/2025" } ] }