{ "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": "2955842-2024-22117", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241120", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20241024", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "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": "FR", "manufacturer_contact_area_code": "408", "date_added": "20241120", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230519", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2008784", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241120", "brand_name": "DA VINCI XI", "generic_name": "SURGEON SIDE CONSOLE, RECONDITIONED", "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": "380723-15", "catalog_number": "380723", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20241119", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874115374", "udi_public": "(01)00886874115374", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Physical Resistance/Sticking", "Physical Resistance/Sticking" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/06/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241120", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20241024", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20733511", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241024", "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": "360213188", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION: INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS THAT WERE USED DURING THIS REPORTED EVENT; HOWEVER, ISI RECEIVED THE PEDAL ENERGY FOOTREST (BLUE PEDAL) TO PERFORM FAILURE ANALYSIS (FA) AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FOOTREST WAS INSTALLED ONTO AN IN-HOUSE SYSTEM AND THE RIGHT BLUE FOOT PEDAL WAS NOT WORKING PROPERLY WHEN USED." }, { "mdr_text_key": "360213189", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "357117441", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE INVESTIGATION CONFIRMED A DEFECTIVE RIGHT BLUE PEDAL ON THE SURGEON SIDE CONSOLE AND REPLACED THE BLUE PEDAL. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC (ISI) RECEIVED THE BLUE PEDAL, BUT THE FAILURE ANALYSIS INVESTIGATIONS HAS NOT BEEN COMPLETED. A REVIEW OF THE INSTRUMENT LOG FOR THE MCS INSTRUMENTS SHOWED THAT THE INSTRUMENTS WERE USED IN SUBSEQUENT PROCEDURES AFTER THE ALLEGED EVENT REPORTED IN THIS RECORD. MCS (PRODUCT NUMBER: 470179-19 / LOT NUMBER: K18240502-0296) ASSOCIATED WITH THIS EVENT, SHOWED THAT THE INSTRUMENT WAS LAST USED ON 11/13/2024 ON SYSTEM SL1229. THE INSTRUMENT HAD 2 USES REMAINING AFTER LAST USE. MCS (PRODUCT NUMBER: 470179-21 / LOT NUMBER: K11240822-0242) ASSOCIATED WITH THIS EVENT, SHOWED THAT THE INSTRUMENT WAS LAST USED ON 11/15/2024 ON SYSTEM SL1229. THE INSTRUMENT HAD 3 USES REMAINING AFTER LAST USE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION 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": "357117442", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOLITHOTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS CONTINUED TO COAGULATE WITHOUT THE SURGEON PRESSING THE BLUE PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THE ISSUE OCCURRED AT THE BEGINNING OF THE PROCEDURE, WHEN THE SURGEON WAS PERFORMING DISSECTION. DURING THE INCIDENT, THE TIPS OF THE MCS INSTRUMENT WERE IN CONTACT WITH PERITONEUM TISSUE; HOWEVER, THE SURGEON MOVED THE INSTRUMENT AWAY FROM THE TISSUE TO AVOID THERMAL DAMAGE. A TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE, AND SUGGESTED THAT THE STAFF REPLACE THE MCS INSTRUMENT, THE MONOPOLAR CAUTERY CORD, AND RESTART THE ERBE GENERATOR; BUT THE ISSUE PERSISTED. THE TSE REVIEWED THE EVENTS LOG AND FOUND THAT THE RIGHT BLUE PEDAL ON THE SSC, THAT CORRESPONDED TO THE MCS INSTRUMENT, WAS STUCK IN THE DOWN POSITION. THE TSE SUGGESTED THAT BIOMED CHECK THE BLUE PEDAL AND MAKE SURE THERE WAS NO OBSTRUCTION, AND STAFF CONFIRMED THAT THE BLUE PEDAL WAS STUCK IN THE DOWN POSITION. WHILE THE TSE ADVISED THE SURGEON TO PROCEED WITH THE PROCEDURE USING THE EXTERNAL PEDAL; THE SURGEON STATED THAT THE BLUE PEDAL WAS WORKING AGAIN. THE PROCEDURE WAS EXTENDED BY AN HOUR, WHICH THE SURGEON STATED THAT THE PATIENT IS AT A HIGHER RISK OF A SURGICAL SITE INFECTION; HOWEVER, THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. A FIELD SERVICE ENGINEER WAS REQUESTED TO FURTHER INVESTIGATE THE BLUE PEDAL. THE MCS INSTRUMENTS WOULD NOT BE RETURNED, BECAUSE THE ISSUE ORIGINATED FROM THE MONOPOLAR PEDAL ON THE SURGICAL CART." } ], "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": "12/26/2024" } ] }