{ "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": "2955842-2013-05062", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131106", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120214", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131107", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "571795", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131106", "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": "", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20131106", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Great Vessel Perforation", "Injury", "Vascular Dissection" ] } ], "distributor_city": "", "date_report": "20131007", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3453833", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131007", "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": "3942412", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL DOCUMENT REGARDING A PATIENT THAT UNDERWENT AN ATTEMPTED DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR ABNORMAL UTERINE BLEEDING AND DYSMENORRHEA. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED INJURIES DURING TROCAR PLACEMENT. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT HAS A HISTORY OF ABNORMAL UTERINE BLEEDING AND DYSMENORRHEA. HER CONDITION WAS INITIALLY TREATED CONSERVATIVELY BUT DUE TO HER CONTINUED SYMPTOMS, SHE OPTED TO PROCEED WITH A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. UPON TROCAR PLACEMENT FOR THE DA VINCI HYSTERECTOMY PROCEDURE, BLOOD BEGAN POURING OUT OF A PORT SITE. IT WAS NOT SPECIFIED IF THE TROCAR WAS AN ISI PRODUCT. A VASCULAR SURGEON WAS CONTACTED FOR AN EMERGENT MANAGEMENT OF A SUSPECTED AORTIC INJURY. THE VASCULAR SURGEON ADVISED THE SURGICAL STAFF TO HOLD PRESSURE ON THE AORTA UNTIL HE ARRIVED. THE PATIENT REPORTEDLY BECAME EXTREMELY HYPOTENSIVE (BLOOD PRESSURE=60/44 MM HG) DUE TO THE MASSIVE BLOOD LOSS. MULTIPLE BLOOD TRANSFUSIONS WERE GIVEN IN AN ATTEMPT TO STABILIZE HER CONDITION. THE VASCULAR SURGEON ARRIVED 25 MINUTES LATER AND MADE A MIDLINE ABDOMINAL INCISION. WHILE EXPLORING THE ABDOMINAL CAVITY, THE VASCULAR SURGEON DISCOVERED THAT NOT ONLY WAS THE AORTA INJURED BUT ALSO THE TRANSVERSE COLON AND LEFT COMMON ILIAC ARTERY. THE LEFT COMMON ILIAC ARTERY WAS COMPLETELY TRANSECTED. THE VASCULAR SURGEON REPAIRED THE MULTIPLE INJURIES AND ESTIMATED 5 LITERS BLOOD LOSS. THE VASCULAR SURGEON ADVISED THE GYNECOLOGIST THAT PROCEEDING WITH THE HYSTERECTOMY WOULD NOT BE IN THE PATIENT'S BEST INTEREST. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE SHE REQUIRED MECHANICAL VENTILATION FOR 2 DAYS. SHE REMAINED IN THE ICU FOR THE MAJORITY OF HER 2 WEEK HOSPITALIZATION. HER HOSPITAL COURSE WAS COMPLICATED BY A POSTOPERATIVE ILEUS, WHICH REQUIRED GASTRIC TUBE PLACEMENT AND HYPERALIMENTATION FOR TREATMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. FOLLOWING HER DISCHARGE ON (B)(6) 2012, THE PATIENT REQUIRED MULTIPLE FOLLOW-UP APPOINTMENTS AND WAS INFORMED THAT SHE WOULD REQUIRE FURTHER SURGICAL INTERVENTIONS FOR THE TREATMENT OF HER ILIAC ARTERY INJURY IN THE FUTURE. THE PATIENT CONTINUES TO SUFFER FROM ABNORMAL UTERINE BLEEDING AND DYSMENORRHEA SINCE THE HYSTERECTOMY WAS NOT PERFORMED. ON 11/06/2013, ISI SPOKE WITH THE SITE'S RISK MANAGER. THE SITE CONFIRMED THAT THE DA VINCI SYSTEM NEVER DOCKED TO THE PATIENT AND WAS NOT INVOLVED WITH THE REPORTED INJURY. HOWEVER, THE TROCAR THAT WAS INVOLVED WITH THE REPORTED INJURY WAS AN INTUITIVE CAMERA CANNULA. THE SITE WAS UNABLE TO PROVIDE A PRODUCT DETAILS OF THE CANNULA." }, { "mdr_text_key": "11215122", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN INJURY DURING TROCAR PLACEMENT BEFORE AN ATTEMPTED DA VINCI SURGICAL HYSTERECTOMY PROCEDURE." } ], "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": "" } ] }