{ "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": "2955842-2023-18060", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230829", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20230801", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230829", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190627", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2082626", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230829", "brand_name": "DA VINCI XI", "generic_name": "VISION SIDE SYSTEM", "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": "381121-36", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230809", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874110898", "udi_public": "(01)00886874110898", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Connection Problem", "Connection Problem" ], "reporter_state_code": "ND", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/03/2023", "mfr_report_type": "Follow-Up", "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": "20230829", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20230803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17645008", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230803", "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": "322212264", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE THAT TIP-UP FENESTRATED GRASPER INSTRUMENT HAD ENGAGEMENT ISSUES. THE PROCEDURE WAS COMPLETED AS AN OPEN PROCEDURE. BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE TIP-UP FENESTRATED GRASPER INSTRUMENT HAD ENGAGEMENT ISSUES, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND THE COMPLAINT REGARDING THE ENGAGEMENT ISSUES WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE INSTRUMENT FAILED MECHANICAL ENGAGEMENT WHEN PLACED IN THE SYSTEM. THE INSTRUMENT INPUTS FAILED TO ENGAGE WITH THE STERILE ADAPTER ON 3 OUT OF 3 ATTEMPTS. THE SYSTEM DISPLAYED ERROR CODE \"22020\", WHICH CONFIRMS AN ENGAGEMENT ERROR. REVIEW OF THE LOGS DID NOT SHOW ANY ENGAGEMENT FAILURES. THE INSTRUMENT WAS FOUND TO HAVE AN INPUT DISK CRACKED. A HAIRLINE CRACK WAS FOUND ON GRIP INPUT DISK #7. AS A RESULT, THE INSTRUMENT FAILED TO ENGAGE. THE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES." }, { "mdr_text_key": "322212265", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE THAT TIP-UP FENESTRATED GRASPER INSTRUMENT HAD ENGAGEMENT ISSUES. THE PROCEDURE WAS COMPLETED AS AN OPEN PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED TO THE INITIAL REPORTER THAT THE INSTRUMENT DIDN'T WORK AND/OR BROKE DURING THE PROCEDURE AND THAT THE PROCEDURE WAS CHANGED TO AN OPEN PROCEDURE. REPORTEDLY, THE CONVERSION TO AN OPEN PROCEDURE DID NOT HAVE ANYTHING TO DO WITH THE INSTRUMENT BREAKING." }, { "mdr_text_key": "336633823", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO SECTION D FOR THE UPDATED PRODUCT INFORMATION." }, { "mdr_text_key": "336633824", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/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": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/31/2023" } ] }