{ "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": "2955842-2015-01444", "type_of_report": [ "" ], "product_problem_flag": "", "date_received": "20151125", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120622", "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": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "779271", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151125", "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", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20151125", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20151030", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5251078", "removal_correction_number": "", "number_devices_in_event": "", "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": "32174256", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE VESSEL INJURY. PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT SUSTAINED A THROUGH-AND-THROUGH PERFORATION OF THE AORTA THAT HAD OCCURRED DURING TROCAR INSERTION BY THE SURGICAL TEAM. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW SINCE THE DA VINCI SURGICAL SYSTEM WAS NEVER DOCKED TO THE PATIENT OR USED DURING THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A PLANNED DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT SUSTAINED A PERFORATION OF THE AORTA DURING TROCAR INSERTION, EXPERIENCED HEMORRHAGING, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE. IT IS ALSO UNCLEAR IF THE VESSEL INJURY INVOLVED AN ISI TROCAR OR A TROCAR FROM A 3RD-PARTY MANUFACTURER." }, { "mdr_text_key": "32174257", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO SUSTAINED A VESSEL INJURY WHILE UNDERGOING A PLANNED DA VINCI-ASSISTED HYSTERECTOMY ON (B)(6) 2012 FOR A SYMPTOMATIC, 15 TO 16-WEEK SIZE FIBROID UTERUS. THE PATIENT SUBSEQUENTLY PASSED AWAY THAT SAME DAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE DA VINCI OPERATIVE REPORT, AT THE BEGINNING OF THE SURGICAL PROCEDURE THE LAPAROSCOPE WAS INTRODUCED AND THE ABDOMEN WAS INSUFFLATED. AT THAT POINT, NO EVIDENCE OF SIGNIFICANT BLEEDING WAS OBSERVED. FOUR TROCARS WERE THEN PLACED WITHOUT DIFFICULTY AND UNDER DIRECT VISUALIZATION WITH THE LAPAROSCOPE. HOWEVER, 1-2 MINUTES AFTER THE LAST TROCAR WAS INSERTED, ANESTHESIA INFORMED THE SURGEON THAT THE PATIENT'S BLOOD PRESSURE HAD COMPLETELY BOTTOMED OUT. THE SURGEON BRIEFLY INSPECTED THE PELVIS AND ABDOMINAL CAVITY AND DID NOT SEE ANY EVIDENCE OF ACTIVE BLEEDING. THE SURGEON SUSPECTED A VASCULAR INJURY AND MADE THE DECISION TO CONVERT TO OPEN SURGERY. THE SURGEON IDENTIFIED A TROCAR INJURY SITE WITH SCANT BLEEDING AND IMMEDIATELY APPLIED PRESSURE TO THE SITE. TWO VASCULAR SURGEONS WERE CALLED INTO THE OPERATING ROOM. A THROUGH-AND-THROUGH HOLE WAS FOUND IN THE PATIENT'S AORTA IN ADDITION TO A LARGE VENOUS HOLE. THE VENOUS INJURY WAS LIGATED AND THE AORTA WAS CLAMPED AROUND THIS. DESPITE AGGRESSIVE RESUSCITATION WITH BLOOD AND FLUID REPLACEMENT, THE PATIENT PASSED AWAY. ACCORDING TO THE DEATH SUMMARY, THE FOLLOWING IS NOTED: AT THE TIME OF SURGERY, THERE WAS AN INADVERTENT TROCAR INJURY TO THE AORTA AND THIS ULTIMATELY LED TO A MASSIVE RETROPERITONEAL BLEED WHICH CAUSED HYPOVOLEMIA AND ULTIMATELY CARDIAC ARREST LEADING TO HER DEATH. PER THE AUTOPSY SUMMARY, PERTINENT FINDINGS INCLUDED A THROUGH-AND-THROUGH PERFORATION OF THE ABDOMINAL AORTA JUST ABOVE THE BIFURCATION. THE AUTOPSY REPORT ALSO NOTES, IN MY OPINION BASED ON THE AUTOPSY FINDINGS AND CLINICAL INFORMATION AVAILABLE TO ME AT THIS TIME, THIS PATIENT DIED AS A RESULT OF PERFORATION OF THE ABDOMINAL AORTA." } ], "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": "" } ] }