{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2018-10422", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20180802", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20180702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20180802", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "584590", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180802", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ASSY, PSCART, IS2000, 4-ARM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380430-03", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Device Handling Problem", "Device Handling Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20180802", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bone Fracture(s)", "Bone Fracture(s)" ] } ], "distributor_city": "", "date_report": "20180709", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7745018", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180709", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "115899790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2018, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE DROVE THE SYSTEM IN FORWARD AND REVERSE FOR OVER 30 STARTS AND STOPS, ENSURING THAT THE PSC WOULD STOP AS SOON AS ONE OR BOTH OF THE SWITCHES WERE RELEASED. ACCORDING TO THE FSE, THE SYSTEM LOGS DID NOT SHOW ANY CART DRIVE ERRORS. THE FSE SPOKE WITH SEVERAL STAFF MEMBERS AT THE SITE AND EACH MEMBER STATED THAT THEY HAVE NEVER HAD THE CART CONTINUE TO DRIVE ONCE ONE OF THE TILLER SWITCHES WERE RELEASED. THE FSE BROUGHT IN THE CHARGE NURSE TO SHOW THAT THE PSC WAS OPERATING CORRECTLY. THE CHARGE NURSE WAS REPORTEDLY SATISFIED WITH THE CART'S DRIVE AND THE PROPER FUNCTION OF THE TILLER SWITCHES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE SUSTAINED A FRACTURED HAND AND TORN LIGAMENT IN HER HAND WHILE MOVING A PSC. THE INITIAL REPORTER ALLEGED THAT THE PSC KEPT MOVING AFTER THE CART DRIVE SWITCH AND THROTTLE WERE RELEASED. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE PSC OCCURRED. A FSE INSPECTED THE PSC AND WAS UNABLE TO REPRODUCE THE ALLEGED CUSTOMER ISSUE. THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE DETERMINED." }, { "mdr_text_key": "115899791", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE'S HAND WAS POSSIBLY FRACTURED WHILE POSITIONING A PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER, WHEN THE CART DRIVE SWITCH AND THROTTLE WERE RELEASED, THE PSC ALLEGEDLY KEPT MOVING AND THE NURSE'S HAND WAS CAUGHT BETWEEN THE CART DRIVE HANDLE AND THE WALL. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE REPORTER, A NURSE, INDICATED THAT THE EVENT OCCURRED ON (B)(6) 2018. ACCORDING TO THE REPORTER, ANOTHER NURSE WAS ATTEMPTING TO MOVE THE PSC OUT OF THE WAY SINCE IT WAS INTERFERING WITH A BACK TABLE. THE DAY THE EVENT OCCURRED, THE NURSE'S HAND REPORTEDLY WAS SWOLLEN. THE FOLLOWING DAY, HER HAND KEPT \"BOTHERING HER\" SO SHE HAD AN X-RAY PERFORMED. A BROKEN BONE WAS IDENTIFIED AROUND THE KNUCKLE AREA OF ONE OF HER FINGERS ON THE RIGHT HAND. IN ADDITION, THE REPORTER INDICATED THAT A TORN LIGAMENT WAS IDENTIFIED. AS A RESULT, A HARD CAST WAS INITIALLY PLACED ON THE NURSE'S HAND. HOWEVER, THE NURSE WAS APPARENTLY ALLERGIC TO SUBSTANCES ON THE CAST. THEREFORE, THE HARD CAST WAS REPLACED WITH A SOFT CAST. THE NURSE WAS REPORTEDLY USING A \"BOXER SPLINT\" AND WAS DOING DESK WORK AT THE SITE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }