{ "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": "2955842-2024-11536", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240227", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20240130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240227", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200305", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "102076", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240227", "brand_name": "DA VINCI", "generic_name": "CANNULA, STANDARD, REUSABLE", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "470002-08", "catalog_number": "470002", "lot_number": "VE200701", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240206", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/04/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20240227", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240130", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18792690", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240130", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "339348938", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. VISUAL INSPECTION FOUND DAMAGE TO THE CANNULA TIP, WITH INDENTATIONS AROUND THE RIM. THE CANNULA WAS TESTED WITH A 0.352\" GAGE PIN, WHICH PASSED FREELY WITHOUT RESISTANCE. SMALL FRAGMENTS OF DEBRIS WERE FOUND INSIDE THE CANNULA. A REVIEW OF A PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: FROM THE COLOR OF THE METAL SHAVINGS IN THE PICTURE, IT IS LIKELY THAT THEY CAME FROM THE VSE SHAFT SCRATCHING AGAINST THE METAL BURR/CHIP INSIDE THE CANNULA." }, { "mdr_text_key": "339348939", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336371985", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION." }, { "mdr_text_key": "336371986", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED TO INFORM THAT THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS BEING REMOVED FROM THE CANNULA WHEN SHAVINGS OF THE SHAFT OF THE VSE FELL INSIDE THE PATIENT. THE SITE NOTED THERE WAS A METAL BURR OR CHIP INSIDE THE CANNULA THAT CAUSED THE SHAFT OF THE VSE TO BE SCRAPED DURING REMOVAL. THE CANNULA WAS THEN REMOVED, AND THE GAUGE PIN WAS USED, WHICH PASSED THE GAUGE TEST. DURING VISUAL INSPECTION OF THE CANNULA, THE SITE NOTED A METAL PIECE INSIDE OF THE CANNULA, WHICH CAUSED DAMAGE TO THE VSE. THE SITE OPENED A NEW VSE AND A NEW CANNULA AND CONTINUED WITH THE PROCEDURE AS EXPECTED. REMOVAL OF THE METAL-LIKE SHAVINGS THAT FELL INSIDE THE PATIENT WAS RETRIEVED. NO SYSTEM ERRORS OR COMPLICATIONS WERE REPORTED. NO INJURY TO THE PATIENT WAS NOTED. THE SITE INFORMED THEY PLANNED ON SENDING BACK THE CANNULA AND THE VSE FOR FURTHER INVESTIGATION. A PHOTO WAS ADDITIONALLY PROVIDED FOR FURTHER REVIEW. THE SITE FURTHER REPORTED THE CANNULAS WERE INSPECTED BY THEIR STERILE PROCESSING DEPARTMENT PRE- AND POST-STERILIZATION AND THE GAUGE PIN WAS USED FOR INSPECTION. IT WAS UNKNOWN IF THE PATIENT REQUIRED ANY UNPLANNED MEDICAL/SURGICAL INTERVENTION. THE FRAGMENTS WERE RETRIEVED, BUT IT IS UNKNOWN HOW THE FRAGMENTS WERE RETRIEVED. THE FRAGMENT IS AVAILABLE FOR RETURN. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/29/2024" } ] }