{ "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": "HOSPITAL", "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": "2955842-2014-02372", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140418", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140320", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140418", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "238343", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140418", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P8", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20140418", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Swelling", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20140320", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3759154", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140320", "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": "4468595", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A NURSE INJURED HER HAND WHILE ATTEMPTING TO MOVE THE PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PSC WAS ABOUT 1 INCH FROM THE WALL AND WAS IN NEUTRAL WHEN THE NURSE GRABBED THE HANDLE OF THE PSC IN AN AWKWARD POSITION. AT THAT SAME TIME, A SURGICAL TECHNICIAN SWITCHED THE PSC FROM NEUTRAL TO DRIVE. AT THAT POINT, THE PSC REPORTEDLY LURCHED BACKWARDS AND CRUSHED THE NURSE'S HAND BETWEEN THE PSC AND WALL. THE NURSE DID NOT BELIEVE THAT SHE ACTIVATED THE HAND CONTROL OF THE PSC. THE NURSE HAD TO GO TO THE EMERGENCY ROOM (ER) AND AN X-RAY WAS PERFORMED. NO BONE FRACTURES WERE FOUND. THE NURSE WAS FOUND TO HAVE SOFT TISSUE DAMAGE AND SWELLING. NO BRUISING WAS OBSERVED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED FROM WHAT HE RECALLS, THE NURSE WAS GIVEN A BAG OF ICE FROM THE ER TO TREAT THE SWELLING. NO DRESSINGS OR BANDAGES WERE GIVEN TO TREAT THE NURSE. AT THIS TIME, THE INITIAL REPORTER STATED THAT THE NURSE IS BACK AT WORK AND IS DOING FINE. ON (B)(4) 2014, ISI ALSO CONTACTED THE FIELD SERVICE ENGINEER (FSE). ACCORDING TO THE FSE, HE SPOKE TO THE SITE'S ROBOTICS COORDINATOR. THE ROBOTICS COORDINATOR INFORMED THE FSE THAT THERE WAS NO PROBLEM WITH THE PSC AND THE REPORTED ISSUE WITH THE PSC WAS RELATED TO USER-ERROR BY THE NURSE. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR. HE INDICATED THAT THE NURSE AND A SURGICAL TECH WERE ATTEMPTING TO MOVE THE PSC THAT WAS PLACED AGAINST A WALL WHEN THE EVENT OCCURRED. THE NURSE HAD PLACED HER HAND BETWEEN THE HANDLE OF THE PSC AND THE WALL WHILE THE SURGICAL TECH WAS CHANGING THE SHIFT SWITCHES FROM NEUTRAL TO D (DRIVE) ON THE PSC. AFTER THE SURGICAL TECH HAD CHANGED ONE SHIFT SWITCH TO DRIVE, THE NURSE CLAIMED THAT THE PSC JERKED AND HER HAND WAS CRUSHED. AT THE TIME THE EVENT OCCURRED, THE SURGICAL TECH WAS REPORTEDLY WALKING AROUND THE PSC TO CHANGE THE SECOND SHIFT SWITCH TO DRIVE. THE ROBOTICS COORDINATOR STATED THAT THE NURSE WAS TREATED IN THE ER WITH AN UNSPECIFIED ANTI-INFLAMMATORY MEDICATION AND AN ICE PACK. X-RAYS WERE NEGATIVE FOR FRACTURES. THE ROBOTICS COORDINATOR INDICATED THAT THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE WITH THE PSC." }, { "mdr_text_key": "11865790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY TO THE NURSE'S HAND. AT THIS TIME, IT IS UNCLEAR IF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED OR IF THE NURSE'S INJURY CAN BE ATTRIBUTED TO USE-ERROR. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE ATTEMPTING TO MOVE THE PSC, THE NURSE'S HAND WAS INJURED, AN X-RAY WAS PERFORMED IN THE ER, AND SHE WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION." } ], "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": "" } ] }