{ "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": "2955842-2025-45218", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251114", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250801", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20251114", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250605", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2810582", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251114", "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": "K10250605", "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(17)270630(10)K10250605", "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": "12/01/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260310", "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": "20251114", "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": "20251218", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23558667", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251022", "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": "390683873", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390683874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 5-12MM, UNIVERSAL SEAL WAS ANALYZED AND FOUND TO HAVE A TEAR ON THE BLACK RUBBER DUCKBILL. THE TORN PIECE WAS RETURNED WITH THE SEAL." }, { "mdr_text_key": "385243305", "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": "385243306", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RENAL CYST DECORTICATION SURGICAL PROCEDURE, DURING THE PROCESS OF INSERTING AN 8MM MONOPOLAR CURVED SCISSOR (MCS) FOR SURGERY, IT WAS DISCOVERED THAT A PART OF THE RUBBER PACKING INSIDE THE 5-12MM SEAL HAD FALLEN INTO THE ABDOMINAL CAVITY. AFTER REMOVING THE INSTRUMENT AND CHECKING THE SEAL, IT WAS FOUND THAT THE INNER RUBBER PACKING, WHICH SHOULD HAVE BEEN SPLIT IN A CROSS SHAPE, WAS COMPLETELY ATTACHED, PREVENTING THE INSERTION OF THE INSTRUMENT. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED BEFORE USE; NO DAMAGE WAS FOUND. THE ISSUE OCCURRED IMMEDIATELY AFTER INSTRUMENT INSERTION AND WAS SUSPECTED TO BE DUE TO A DEFECTIVE ACCESSORY. NO FUNCTIONAL ISSUES WERE OBSERVED DURING THE PROCEDURE. THE ACCESSORY DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS, AND NO FRAGMENTS FELL INSIDE THE PATIENT DUE TO COLLISION. THERE WAS NO RESISTANCE WHEN REMOVING THE INSTRUMENT, AND NO DAMAGE TO THE CANNULA OR INSTRUMENT WAS SEEN AFTER THE EVENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND VISUALLY CONFIRMED; NO ADDITIONAL SURGERY OR POST-OPERATIVE IMAGING WAS NEEDED. THE PROCEDURE WAS COMPLETED ROBOTICALLY; NO ADDITIONAL PATIENT INJURY OR POST-SURGICAL COMPLICATIONS OCCURRED. THE INSTRUMENT AND FRAGMENT WILL BE RETURNED TO ISI FOR EVALUATION. NO PHOTOS OR VIDEO OF THE EVENT WERE AVAILABLE." } ], "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": "12/18/2025" } ] }