{ "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": "2955842-2014-01986", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140407", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140307", "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": "20140407", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "209626", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140407", "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": [ "Failure to Deliver Energy", "Loss of Power" ], "reporter_state_code": "OK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20140407", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20140307", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3728656", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140307", "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": "4279134", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON COULD NOT GET THE HARMONIC ACE CURVED SHEARS INSTRUMENT OR MARYLAND BIPOLAR FORCEPS INSTRUMENT TO ENERGIZE. DUE TO THE REPORTED ISSUE, THE INITIAL REPORTER INDICATED THAT THE PATIENT LOST 1300 CC OF BLOOD. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE ROBOTICS COORDINATOR, THE HOSPITAL HAD LOST POWER TO THE ENTIRE OR IN THE MORNING AND THE SURGICAL STAFF HAD UNPLUGGED AND RE-PLUGGED THE CABLES IN ORDER TO GET THEIR SYSTEMS ALL TURNED BACK ON FOR THE DA VINCI SURGICAL PROCEDURE. DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO ACTIVATE THE HARMONIC ACE CURVED SHEARS INSTRUMENT AND MARYLAND BIPOLAR FORCEPS INSTRUMENT BUT NOTICED THAT THEY WOULD NOT WORK. AFTER THE ROBOTICS COORDINATOR UNPLUGGED AND RE-PLUGGED THE INSTRUMENT CABLES LEADING TO THE ELECTROSURGICAL UNIT (ESU), THE INSTRUMENTS BEGAN TO WORK PROPERLY FOR THE REST OF THE PROCEDURE. LATER THAT SAME DAY, THE FSE PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE CHECKED THE SENSOR STATUS FOR FOOT PEDAL ACTIVATION ON THE SYSTEM WHICH PASSED. THE FSE VERIFIED THAT THE FOOT PEDALS WOULD ACTIVATE IN NORMAL OPERATION MODE. THE FSE ALSO TEST DROVE THE SYSTEM AND NO ISSUES WERE OBSERVED. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. ON (B)(4) 2014, ISI CONTACTED THE ROBOTICS COORDINATOR. SHE INDICATED THAT DUE TO THE BLOOD LOSS, THE PATIENT RECEIVED A BLOOD TRANSFUSION DURING THE SURGICAL PROCEDURE. HOWEVER, THE ROBOTICS COORDINATOR INDICATED THAT THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID NOT DEVELOP ANY POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "11860720", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, THE FSE PERFORMED A FIELD EVALUATION AT THE SITE AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE CUSTOMER REPORTED FAILURE MODE. DURING THE REPORTED EVENT, THE ROBOTICS COORDINATOR RESOLVED THE ISSUE BY UNPLUGGING AND RE-PLUGGING THE INSTRUMENT CABLES CONNECTED TO THE GENERATOR. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT LOST 1300 CC OF BLOOD AND RECEIVED A BLOOD TRANSFUSION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. DURING THE SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ISSUE WHERE THE INSTRUMENTS WOULD NOT ENERGIZE." } ], "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": "" } ] }