{ "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": "2955842-2025-50205", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260105", "manufacturer_address_2": "", "pma_pmn_number": "K202571", "date_of_event": "20251211", "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": "", "date_added": "20260105", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251030", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "17639", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260105", "brand_name": "DA VINCI", "generic_name": "ACCESS PORT KIT", "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": "430073-05", "catalog_number": "430073", "lot_number": "K10251030", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20251218", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874119546", "udi_public": "(01)10886874119546(10)K10251030", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation" ], "reporter_state_code": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/03/2026", "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": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260105", "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" ] } ], "distributor_city": "", "date_report": "20260223", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23959580", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251211", "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": "389179031", "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 PORT KIT ACCESSORY WAS ANALYZED AND FOUND TO HAVE THE PORT DISLODGED. FOR CLARIFICATION, THE WOUND RETRACTOR KIT WAS RETURNED WITH ALL FOUR OF THE OF THE ACCESS PORT CHAMBERS PROTECTIVE FLAPS DISLODGED. ALL FOUR PROTECTIVE CAPS WERE RETURNED. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE WOUND RETRACTOR KIT WAS FOUND TO HAVE A DETACHED FRAGMENT. THIS CODE WAS ADDED AS A RESULT OF THE PROTECTIVE FLAPS OF THE ACCESS PORT CHAMBER BECOMING DISLODGED. ALL FOUR PROTECTIVE FLAPS WERE RETURNED. THE WOUND RETRACTOR KIT WAS FOUND TO HAVE THE PROTECTIVE FLAPS OF THE ACCESS PORT CHAMBER CRACKED. THREE OUT OF THE FOUR FLAPS WERE FOUND TO BE CRACKED AT THE LATCH. THERE WAS NO MATERIAL MISSING. THE ACCESS PORT CHAMBER WAS FOUND TO HAVE A TEAR ON THE ACCESS PORT SEAL. THE TEAR MEASURED APPROXIMATELY 7.14MM IN LENGTH. THERE WAS NO MATERIAL MISSING." }, { "mdr_text_key": "389179032", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NURSE OPENED UP AND USED A SINGLE ACCESS SINGLE PORT KIT. WHEN THE SUTURE WENT THROUGH FINE, A PART OF THE FLAP (YELLOW IN COLOR) POPPED OFF AND FELL INTO THE PATIENT. THE STAFF WAS ABLE TO GET IT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "395142024", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 03-FEB-2026, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FURTHER INVESTIGATION: THE ACCESS PORT ACCESSORY WAS ANALYZED AND FOUND TO HAVE DISLODGED AND DAMAGED PROTECTIVE FLAPS, A TORN SEPTUM SEAL, AND A TORN DUCKBILL. THE PROTECTIVE FLAPS, SEPTUM, AND DUCKBILL ALL RESIDED AT THE SAME OPENING OF THE ACCESS PORT CHAMBER WHICH IS TYPICALLY REFERRED TO AS THE ROTATING ACCESS PORT SEAL. THE ROTATING ACCESS PORT SEAL WAS INSPECTED FURTHER; THE 4 PROTECTIVE FLAPS WERE INSPECTED, AND 3 OF THEM WERE FOUND TO BE TORN AT THE LOCATION THAT INTERFACES WITH THE PUCKS WITHIN THE SEAL SUBASSEMBLY. THE PUCKS WERE INSPECTED AND APPEARED TO BE INTACT AND PROPERLY ASSEMBLED, AS THERE WERE NO ABNORMAL GAPS. INSPECTION OF THE UNDERSIDE OF THE SEAL SUBASSEMBLY WHERE THE FLAPS ORIGINATED FROM (COMMONLY REFERRED TO AS THE ROTATING ACCESS PORT SEAL) FOUND A TORN DUCKBILL SEAL. THE UNDERSIDE OF THE SEPTUM AND THE SURROUNDING PUCK COMPONENT APPEARED TO HAVE RESIDUAL LUBRICATION, POTENTIALLY CONFIRMING THAT LUBRICATION WAS APPLIED TO THE AREA AS EXPECTED DURING MANUFACTURING." }, { "mdr_text_key": "395142025", "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/23/2026" } ] }