{ "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": "2955842-2025-45177", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20251113", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251029", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20251113", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240521", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2779515", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251113", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "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": "380941-52", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "No Device Output", "No Device Output" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/02/2025;02/17/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260507", "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": "20251113", "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": [ "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions", "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260303", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23548367", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251029", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "390321327", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION TO B1, B2 AND H2" }, { "mdr_text_key": "390321328", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "394880702", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE CONTROLLER (EC) WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED BUT NOT REPLICATED. IN THE SYSTEM LOGS, ERRORS WERE FOUND ALIGNING WITH THE REPORTED ISSUES, CONFIRMING THAT THE FAULT OCCURRED IN THE FIELD. NO PHYSICAL DAMAGE WAS OBSERVED ON THE EXTERIOR AND INTERIOR OF THE UNIT DURING VISUAL INSPECTION. THE UNIT WAS INSTALLED IN THE GOLDEN SYSTEM WHERE IT WAS PROGRAMMED SUCCESSFULLY AND FUNCTIONED AS EXPECTED. ALL NODES WERE PRESENT AND THE IMAGE WAS CLEAR. THE SYSTEM WAS SET TO RUN 10 POWER CYCLES. AFTER TESTING, THE ERROR LOGS WERE INVESTIGATED BUT NO ERRORS WERE FOUND RELATED TO THE REPORTED EVENT. INVESTIGATION REVEALED THE RELATED SYSTEM ERRORS: A COMMUNICATION ERROR BETWEEN THE SCOPE AND EC OCCURRED, LOSS OF ALL ENDOSCOPE VIDEO TO EC/RESEAT SCOPE CONNECTION, AND FROZEN VIDEO ON THE LEFT AND RIGHT CHANNELS OF THE CAMERA/SCOPE." }, { "mdr_text_key": "394880703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "386188638", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE BUT WITH PORTS PLACED, THE CUSTOMER CALLED IN TO REPORT THEY HAD ISSUES WITH AN ENDOSCOPE. PRIOR TO THE CALL, THE SYSTEM WAS RESTARTED A FEW TIMES. THEY ALSO MENTIONED THAT THEY HAD ISSUES IN THE PAST WITH IMAGE QUALITY FROM MULTIPLE ENDOSCOPES (STREAKS). TECHNICAL SUPPORT ENGINEER (TSE) ADVISED TO CLEAN ENDOSCOPE CONTACTS WITH ALCOHOL AND RESEAT SCOPE A FEW TIMES. ENDOSCOPE WAS NOT RECOGNIZED ANYMORE, AND VISION SIDE CART (VSC) WAS SHOWING TEST BARS. TSE ASKED TO USE A DIFFERENT ENDOSCOPE. THIS ENDOSCOPE WAS RECOGNIZED BUT IMAGE QUALITY WAS BAD. AFTER RESEATING, IT WAS ALSO NOT RECOGNIZED. AT THIS STAGE SURGEON WAS UNSURE IF THE PROCEDURE WILL BE PERFORMED LAPAROSCOPIC OR RESCHEDULED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY." }, { "mdr_text_key": "386188639", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE COULD NOT REPRODUCE THE PROBLEM. THE CAMERA WORKED PROPERLY. THE ENDOSCOPE CONNECTOR (EC) SHOWED SLIGHT SIGNS OF WEARING WITH POSSIBLE INTERMITTENT BAD CONNECTIONS, SO THE EC WAS REPLACED. THE CUSTOMER REPORTED HAVING PROBLEMS WITH TOO WET INSTRUMENTS DELIVERED BACK FROM REPROCESSING WHICH MOST LIKELY CONTRIBUTED TO THE ISSUES WITH THE CAMERAS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE EC." } ], "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": "12/22/2025;03/03/2026" } ] }