{ "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": "2955842-2025-23372", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250604", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250513", "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": "408", "date_added": "20250604", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2173704", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250604", "brand_name": "DA VINCI", "generic_name": "CANNULA 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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20250604", "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": "20250513", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22141144", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250513", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "371654688", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "371654689", "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 CUSTOMER WAS INSERTING A ROBOTIC CLIP APPLIER AND WHEN THE CLIP APPLIER WENT THROUGH THE CANNULA SEAL, A PIECE OF THE BLACK PLASTIC THAT WAS INSIDE FELL INTO THE PATIENT'S ABDOMEN. THE 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 INSTRUMENT AND INSPECTED PRIOR TO USE AND NO DAMAGES WERE NOTED; HOWEVER, THE INTERIOR OF THE CANNULA SEAL WAS NOT. THE TASK BEING PERFORMED AT THE TIME OF THE CANNULA SEAL BREAKING WAS AN INSTRUMENT EXCHANGE. IT WAS UNKNOWN WHAT THE SURGEON BELIEVES WAS THE CAUSE OF THE ACCESSORY BREAKING. IT WAS UNKNOWN HOW LONG THE DEVICE WAS IN USE PRIOR TO THE ISSUE. THERE WERE NO ISSUES WITH THE FUNCTIONALITY OF ACCESSORY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR THE HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. AN INSTRUMENT WAS REMOVED THROUGH THE CANNULA DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. DAMAGE WAS NOTED TO THE CANNULA AFTER THE EVENT OCCURRED. THERE WAS NO DAMAGE TO THE INSTRUMENT. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. ONLY ONE PIECE WAS VISUALIZED FALLING INTO THE PATIENT AND IT WAS RETRIEVED; IT MATCHED THE SIZE OF THE MISSING PART OF THE SEAL. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING FOREIGN OBJECT. THE FRAGMENTED SEAL WAS THROWN AWAY." } ], "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": "" } ] }