{ "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": "2955842-2023-11213", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230310", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230215", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "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": "20230310", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190417", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1055082", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230310", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE 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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Unintended System Motion" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20230310", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "69 YR", "patient_sex": "Female", "patient_weight": "77 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16523253", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230215", "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": "311079305", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE INSTRUMENTS MOVED BACKWARDS WHEN PLACED ON THE ROBOT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER HAD CONVERTED THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. THE SITE WAS USING A 0-DEGREE ENDOSCOPE WHEN THE ISSUE OCCURRED AND THEY WERE UNSURE IF THEY HAD CAMERA UP OR DOWN SELECTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THE PATIENT TOLERATED THE CONVERSION WELL AND THERE WAS NO INJURY TO THE PATIENT." }, { "mdr_text_key": "311079306", "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 COMPLAINT. THE FSE CONTACTED THE INITIAL REPORTER BEFORE END OF DAY (EOD) TO GET MORE INFORMATION ABOUT THE REPORTED ISSUE. THE INITIAL REPORTER INDICATED THAT THE SURGEON DID NOT WANT TO TROUBLESHOOT AND INDICATED THAT THE SYSTEM JUST FELT OFF AND DID NOT WANT TO TROUBLESHOOT OR FIGURE OUT WHAT WAS THE ISSUE BEFORE CONVERTING TO TRADITIONAL LAPAROSCOPIC SURGERY. THE INITIAL REPORTER DID NOT HAVE MUCH INFORMATION, BUT DID INDICATE THAT THE SURGEON REPORTED THAT THE ARMS AND MASTER TOOL MANIPULATORS (MTMS) WERE OPPOSITE. THE SURGEON AT THE TIME DID NOT KNOW HOW TO SWITCH THE INSTRUMENTS ASSIGNMENTS TO THE CORRECT MTMS AS THAT WAS NOT CHECKED DURING TROUBLESHOOTING AS SURGEON AND INITIAL REPORTER DID NOT KNOW WHAT TO CHECK OR WAS NOT FAMILIAR WITH SYSTEM AS ANTICIPATED. THE FSE ARRIVED ONSITE AND PERFORMED SYSTEM TESTING AND SYSTEM VERIFICATION. THE FSE FOUND THAT THE SYSTEM ENTRY GUIDE MANIPULATOR (EGM) WAS ORIENTED 180 DEGREES, CAUSING THE PERCEPTION THAT INSTRUMENTS ARE BEING SWITCHED. FOR EXAMPLE, LEFT BECOMING RIGHT AND RIGHT BECOMING LEFT WHEN FACING THE EGM. THE FSE ALSO NOTICED THE HORIZON COMPASS FOR THE ORIENTATION OF THE CAMERA WAS FLIPPED. THE FSE INFORMED THE CUSTOMER ABOUT THIS USER RELATED ISSUE. THE FSE WAS NOT ABLE TO REPRODUCE OR REPLICATE THE REPORTED ISSUE AS INTUITIVE MOTION WAS CONFIRMED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: DURING A PLANNED DA VINCI-ASSISTED SURGICAL PROCEDURE SURGEON ELECTED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY AS THE INSTRUMENTS WERE NOT MOVING AS EXPECTED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION. IN THIS CASE, THE PATIENT TOLERATED THE CONVERSION WELL. ADDITIONALLY, THE CUSTOMER REPORTED ISSUE CAN BE ATTRIBUTED TO USER ERROR AS THE FSE FOUND THAT THE SYSTEM EGM WAS ORIENTED 180 DEGREES WHICH CAUSED THE PERCEPTION THAT INSTRUMENTS ARE BEING SWITCHED." } ], "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": "" } ] }