{ "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": "2955842-2025-01627", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250219", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250114", "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": "20250219", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240502", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2651066", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250219", "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": "K11240502", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250218", "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)K11240502", "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": "02/20/2025;04/04/2025", "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": "20250219", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250122", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21407476", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250122", "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": "369075835", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADVANCED FAILURE ANALYSIS WAS PERFORMED, AND THE SEAL WAS DISASSEMBLED TO BETTER EXAMINE THE SEPTUM. THE EXAMINATION FOUND THE PRESENCE OF DAMAGE AND A DETACHED FRAGMENT WERE CONFIRMED HOWEVER THE TORN COMPONENT WAS FOUND TO BE THE SEPTUM INSTEAD OF THE DUCKBILL. THE SEAL WAS FOUND TO HAVE A ROUND HOLE IN ITS SEPTUM AND THE FRAGMENT WAS NOT RETURNED WITH THE SEAL. THE HOLE WAS OBSERVED TO BE SMALLER THAN THE EXPECTED OPENING OF THE SEPTUM LOCATED AT THE CENTER. ADDITIONALLY, THE OBSERVED HOLE WAS FOUND TO BE SLIGHTLY OFFSET FROM THE EXPECTED OPENING." }, { "mdr_text_key": "369075836", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "365699892", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "365699893", "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 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": "363858408", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A FRAGMENT OF SILICONE RUBBER FROM A UNIVERSAL SEAL BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMINAL CAVITY. THE EVENT OCCURRED WHEN AN INSTRUMENT WAS BEING EXCHANGED. THE PIECE WAS FOUND INTRAOPERATIVELY AND RETRIEVED DURING THE SAME SURGICAL PROCEDURE. A VISUAL INSPECTION OF THE REMAINING CANNULA SEAL WAS CONDUCTED, AND THE BROKEN PIECES WERE MATCHED TO CONFIRM THAT ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. AN UNSPECIFIED POSTOPERATIVE TEST WAS PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THE RESULTS OF THE TEST WERE NOT PROVIDED. THE PATIENT HAS NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FRAGMENT AND HAS NOT RETURNED TO THE HOSPITAL FOR THIS ISSUE." }, { "mdr_text_key": "363858409", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SEAL FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION HAS NOT BEEN COMPLETED. THE EVENT INVESTIGATION IS IN PROGRESS." } ], "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": "03/13/2025;04/28/2025" } ] }