{ "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": "2955842-2015-00886", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150612", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150513", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "385231", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150612", "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": [ "Self-Activation or Keying" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20150612", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)", "Rupture" ] } ], "distributor_city": "", "date_report": "20150514", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4841021", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150514", "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": "20532673", "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 INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED A VESSEL INJURY, LOST APPROXIMATELY 3 LITERS OF BLOOD, AND RECEIVED A BLOOD TRANSFUSION. HOWEVER, AT THIS TIME, THE CAUSE OF THE VESSEL INJURY IS UNCLEAR." }, { "mdr_text_key": "20149815", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE ELECTROSURGICAL UNIT (ESU) TURNED ON WHILE THE SURGEON WAS DISSECTING WITH A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. AS A RESULT, THE MCS INSTRUMENT CAUTERIZED AND AN ARTERY RUPTURED. THE SURGEON CLAIMED THAT HIS FEET WERE NOT PRESSING ANY PEDALS ON THE SYSTEM. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY AND THE PATIENT REQUIRED SEVERAL UNITS OF BLOOD. ON (B)(6) 2015 A CIRCULATOR, WHO WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE, INDICATED THAT THE SURGEON WAS COLD DISSECTING WITH THE MCS INSTRUMENT WHEN ENERGY FIRED WITHOUT ACTIVATION BY THE SURGEON. THE CIRCULATOR STATED THAT AN ILIAC ARTERY RUPTURED AND BLED AS A RESULT OF THE ISSUE. THE CASE WAS CONVERTED TO OPEN SURGERY AND A VASCULAR SPECIALIST WAS CONSULTED. THE ESTIMATED BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 3 LITERS AND THE PATIENT RECEIVED BLOOD PRODUCTS. ON (B)(6) 2015, AN ISI TECHNICAL FIELD SPECIALIST (TFS) CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE TFS INDICATED THAT THE SITE HAD REPLACED THE ESU AS WELL AS A CABLE CONNECTED TO THE ESU. THE ROBOTICS COORDINATOR INFORMED THE TFS THAT THE DA VINCI SURGICAL SYSTEM HAD BEEN IN USE WITH NO RECURRENCES OF THE REPORTED CUSTOMER ISSUE. ACCORDING TO THE TFS, THE ROBOTICS COORDINATOR ADMITTED THAT THEY HAD BEEN USING A CONMED CABLE WITH THE ESU. THE TFS INFORMED THE ROBOTICS COORDINATOR THAT THE SITE SHOULD NOT BE USING NON-VALIDATED CABLES FOR USE WITH THE DA VINCI SURGICAL SYSTEM. ON 06/08/2015, ISI CONTACTED THE ISI CLINICAL SERVICE REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON CLAIMED THAT HE PURPOSEFULLY KEPT HIS FEET AWAY FROM THE PEDALS BEFORE THE EVENT OCCURRED AND TO AVOID ACCIDENTAL ACTIVATION OF ENERGY. WHILE DISSECTING WITH THE MCS INSTRUMENT, THE SURGEON CLAIMED THAT THE ESU ACTIVATED ON ITS OWN WHICH RESULTED IN THE ILIAC ARTERY BEING CUT. DURING ATTEMPTED SUTURING OF THE VESSEL INJURY, THE VESSEL REPORTEDLY RUPTURED. THE CASE WAS THEN CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. NO OTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }