{ "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": "Death", "report_number": "2955842-2014-03586", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140611", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140512", "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": "20140612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "345385", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140611", "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": "DA", "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": [ "Use of Device Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20140611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20140512", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3867482", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140714", "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": "22344133", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATIONS SUSTAINED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE REPORTED EVENT. 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. 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 SURGEON MADE THE DECISION TO CONVERT THE DA VINCI ADRENALECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER A RENAL VESSEL WAS INJURED. THE PATIENT SUBSEQUENTLY PASSED AWAY AFTER HER VENA CAVA WAS INJURED DURING THE OPEN SURGERY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S VESSEL INJURIES AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "12233166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI SURGICAL PROCEDURE. HE STATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE AND INDICATED THAT THE DA VINCI SURGICAL SYSTEM HAD NOTHING TO DO WITH THE INJURY TO THE PATIENT'S VENA CAVA AND HER SUBSEQUENT DEMISE. THE SURGEON EXPLAINED THAT THE PATIENT HAD METASTATIC CANCER THAT HAD SPREAD TO A HYPERVASCULAR AREA OF THE PATIENT'S ADRENAL GLANDS AND THE SURGICAL PROCEDURE WAS COMPLICATED. DURING DISSECTION OF ONE OF THE PATIENT'S ADRENAL GLANDS, THE SURGEON INADVERTENTLY INJURED A RENAL VEIN. THE SURGEON STATED THAT THE DA VINCI SURGICAL SYSTEM WAS WORKING FINE AND MOVING INTUITIVELY AT THE TIME. THE SURGEON ATTRIBUTED THE COMPLEXITY OF THE CASE TO THE PATIENT'S RENAL VEIN INJURY. IN ORDER TO STOP THE BLEEDING FROM THE RENAL VEIN INJURY, THE SURGEON MADE THE DECISION TO CONVERT THE CASE TO TRADITIONAL OPEN SURGICAL TECHNIQUES. AFTER UNDOCKING THE DA VINCI SYSTEM AND SUCCESSFULLY CONTROLLING THE BLEEDING, THE SURGEON DECIDED TO CONTINUE WITH THE ANDRENALECTOMY PROCEDURE VIA OPEN SURGERY. DURING THE OPEN SURGERY, THE SURGEON STATED HE INJURED THE PATIENT'S VENA CAVA. THE SURGEON DID NOT PROVIDE DETAILS REGARDING HOW THE VENA CAVA WAS INJURED. A VASCULAR SURGEON WAS CALLED INTO THE OPERATING ROOM TO CONTROL THE BLEEDING USING A CLAMP ON THE VENA CAVA. THE VASCULAR SURGEON RECOMMENDED THAT THE PATIENT BE TRANSFERRED TO A TRAUMA CENTER WHERE HER VENA CAVA WAS REPAIRED. THE SURGEON DID NOT HAVE THE PATIENT'S AUTOPSY REPORT; HOWEVER, THE SURGEON STATED THAT ALTHOUGH THE PATIENT RECEIVED NUMEROUS BLOOD TRANSFUSIONS, THE PATIENT ULTIMATELY BLED TO DEATH. ACCORDING TO THE SURGEON, THE CAUSE OF DEATH WAS A HEMORRHAGE. ON (B)(6) 2014, THE SITE'S RISK MANAGER CONTACTED ISI AND PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. SHE INDICATED THAT THE PATIENT'S AUTOPSY REPORT NOTES THE CAUSE OF DEATH WAS INTRAOPERATIVE TRAUMATIC INCISION OF INFERIOR VENA CAVA WITH EXSANGUINATION DUE TO ELECTIVE ROBOTIC ASSISTED ADRENALECTOMY FOR PATHOLOGIC DIAGNOSIS OF RIGHT ADRENAL MASS DUE TO METASTATIC POORLY DIFFERENTIATED NON-SMALL CELL LUNG CARCINOMA, AND WAS A THERAPEUTIC COMPLICATION. ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND THE OR DIRECTOR TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS RESPONSE." }, { "mdr_text_key": "21972029", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING THE FIRST HOUR OF THE DA VINCI ADRENALECTOMY PROCEDURE, THE SURGEON NICKED A BRANCH OF A RENAL VEIN. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) 2. THE SURGEON THEN MADE THE DECISION TO CONVERT THE DA VINCI ADRENALECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES IN ORDER TO SUTURE THE VESSEL. AT AN UNSPECIFIED TIME DURING THE REMAINDER OF THE OPEN SURGICAL PROCEDURE, THE PATIENT'S VENA CAVA WAS INJURED. THE PATIENT WAS THEN TRANSPORTED TO ANOTHER FACILITY AND SUBSEQUENTLY PASSED AWAY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S RENAL ARTERY WAS NICKED BY THE SURGEON. HOWEVER, SHE STATED THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE INJURY TO THE RENAL ARTERY. THE SURGEON THEN MADE THE DECISION TO UNDOCK THE ROBOT FROM THE PATIENT AND TO CONVERT TO OPEN SURGERY TO CONTROL THE BLEEDING FROM THE RENAL ARTERY. AFTER SUTURING THE RENAL ARTERY AND CONTROLLING THE BLEEDING, THE SURGEON PROCEEDED WITH THE ADRENALECTOMY PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. AT AN UNSPECIFIED TIME DURING THE OPEN SURGERY, THE POSTERIOR SIDE OF THE PATIENT'S VENA CAVA WAS INJURED AND ADDITIONAL BLEEDING WAS ENCOUNTERED. THE PATIENT WAS TRANSPORTED TO ANOTHER UNSPECIFIED FACILITY WHERE SHE SUBSEQUENTLY PASSED AWAY THE SAME DAY OF THE EVENT. THE INITIAL REPORTER DID NOT KNOW THE CAUSE OF THE PATIENT'S DEATH. HOWEVER, THE SURGEON REPORTEDLY INFORMED HER THAT THE DA VINCI SURGICAL SYSTEM HAD NOTHING TO DO WITH THE INJURY TO THE PATIENT'S VENA CAVA AND HER SUBSEQUENT DEMISE." } ], "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": "08/13/2014" } ] }