{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5165293", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250127", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241213", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT FAMILY MEMBER OR FRIEND", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20250129", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2480600", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250127", "brand_name": "DA VINCI ASSITED ROBOTIC SYSTEM", "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT", "manufacturer_d_name": "INTUITIVE SURGICAL, INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "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" } } ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20250127", "sequence_number_treatment": [ "BUSPIRONE.", " CALCIUM GUMMIES WITH D3.", " DULCOLAX STOOL SOFTNER.", " HAIR SKIN & NAIL ORAL TABLET.", " HIGH ABSORPTION MAGNESIUM GLYCINATE.", " HYDROXYZINE HYDROCHLORIDE.", " MELATONIN.", " MIRALAX.", " MONTELUKAST.", " NORETHINDRONE.", " PRENATAL MULTIVITAMINS.", " PRESSER VISION AREDS.", " PROBIOTIC FORMULA.", " VENLAFAXINE.." ], "sequence_number_outcome": [ "Required Intervention", " O", " H", " L", " S" ], "patient_age": "35 YR", "patient_sex": "Female", "patient_weight": "47 KG", "patient_ethnicity": "Hispanic", "patient_race": "White", "patient_problems": [ "Anemia", "Cardiac Arrest", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Perforation", "Pleural Effusion", "Pulmonary Edema", "Tachycardia", "Great Vessel Perforation", "Respiratory Failure", "Swelling/ Edema", "Anemia", "Cardiac Arrest", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Perforation", "Pleural Effusion", "Pulmonary Edema", "Tachycardia", "Great Vessel Perforation", "Respiratory Failure", "Swelling/ Edema" ] } ], "distributor_city": "", "date_report": "20250121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "21243515", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary 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": "362378281", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MY 35 YEARS OLD DAUGHTER UNDERWENT ELECTIVE SURGERY TO REMOVE HER UTERUS, USING THE DA VINCI ROBOTIC HD BY LAPAROSCOPY DUE TO FIBROIDS THAT DID NOT RESPONDED TO MEDICAL TREATMENT. SHE WAS PROGRAMED FOR HYSTERECTOMY AND POSSIBLE BILATERAL SALPINGECTOMY. THE SURGERY WAS PERFORMED ON (B)(6) 2024, AT (B)(6) HOSPITAL (B)(6). THE SURGERY WAS PROJECTED TO LAST TWO HOURS, STARTING AT 8 AM. AT ABOUT 2 PM, THE OBG DOCTOR CALLED MY DAUGHTER'S HUSBAND TO SAY, \"THAT THERE WAS A SMALL COMPLICATION\", AND THE PATIENT WOULD STAY AS A PRECAUTION AT THE INTENSIVE CARE UNIT (ICU). THE OBSTETRICS & GYNECOLOGIST (OBG) \"SMALL COMPLICATION, WAS THAT WITH THE DEVICE TROCAR, SHE HAD CUT INTO THE PATIENT'S INFERIOR CAVA VEIN (THE LARGER IN THE BODY), SHE CUT THE PERITONEUM, SHE ALSO CUT PART OF THE INTESTINE AND SOME OF THE MESENTERIC ARTERIAL-VEINS VESSELS. THE LAPAROSCOPIC WAS CONVERTED TO OPEN HYSTERECTOMY. THE ANESTHESIOLOGIST IMMEDIATELY CALLED THE VASCULAR SURGEON FOR AN EMERGENCY REPAIR OF THE VESSELS INVOLVED. A GENERAL SURGEON WAS ALSO CALLED URGENTLY DUE TO DECREASING BLOOD PRESSURE AND SEVERE TACHYCARDIA. THE HYSTERECTOMY AND BILATERAL SALPINGECTOMY WAS COMPLICATED BY INFERIOR VENA CAVA INJURY STATUS POST EMERGENT IVC INJURY REPAIR, S/P ENTEROTOMY WITH ENTERORRHAPHY AND STATUS POST EXPLORATORY LAPAROTOMY ON (B)(6) 2024. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 50ML FROM THIS PROCEDURE WITH APPROXIMATELY 2.5 LITERS OF CLOTTED BLOOD BEING EVACUATED ON ENTRY. THIS CAUSED SEVERE ACUTE SEVERE ANEMIA, SEVERE LOW FIBRINOGEN. PROTEIN CALORIE MALNUTRITION. GROUND GLASS OPACITIES IN THE LUNG BASES WITH MORE CONFLUENT OPACITIES IN THE DEPENDENT PORTIONS OF THE LOWER LOBES. THESE ARE NEW SINCE THE PRIOR STUDY. SMALL BILATERAL PLEURAL EFFUSIONS. THERE IS GENERALIZED ANASARCA THAT IS A SEVERE CONDITION THAT CAUSES WIDESPREAD SWELLING THROUGHOUT THE BODY DUE TO A BUILDUP OF FLUID IN THE BODY'S TISSUES) SKIN STAPLES NOTED ANTERIORLY. A SMALL AMOUNT OF GAS IN THE ANTERIOR SUBCUTANEOUS SOFT TISSUES OF THE ABDOMEN AND WITHIN THE INGUINAL CANALS WAS NOTICED BY THE RADIOLOGIST. FOR THE SEVERE CONDITION A LEFT JUGULAR CENTRAL VENOUS CATHETER. SHE REQUIRED RETURN TO OPERATING ROOM ON (B)(6) 2024 FOR HEMOPERITONEUM WITH ASSISTANCE FROM VASCULAR SURGERY AND WAS FOUND TO HAVE NO ARTERIAL/ VENOUS BLEEDING FROM MAJOR VESSELS; THIS WAS COMPLICATED BY INTRAOPERATIVE CARDIAC ARREST. THE SURGEONS NOTED VENOUS OOZING IS A TYPE OF BLEEDING THAT OCCURS WHEN A VEIN IS TORN OR SEVERED, CAUSING DARK RED BLOOD TO FLOW OUT STEADILY. VENOUS OOZING CAN BE CAUSED BY A NUMBER OF WOUNDS, INCLUDING LACERATIONS, AND PUNCTURES. ACUTE PULMONARY EDEMA DUE TO SHOCK AND VOLUME RESUSCITATION. ACUTE RESPIRATORY FAILURE: DUE TO SHOCK STATE. HEMORRHAGIC SHOCK 35 YEAR OLD CRITICALLY ILL WITH FAILURE OF THE FOLLOWING ORGAN SYSTEMS AND RISK OF DETERIORATION WITHOUT INTERVENTION: RESPIRATORY, CARDIAC, NEUROLOGIC, AND HEMATOLOGIC AMONG OTHER COMPLICATIONS. THE SURGEONS THEN PLACED LAPAROTOMY PADS OVER THE MESENTERY AND FOUR QUADRANTS OF THE ABDOMEN. THE PERITONEUM AT THE BASE OF THE MESOCOLON HAD ALREADY BEEN INCISED DURING HER PRIOR PROCEDURE AND THE AORTA WAS READILY IDENTIFIED. I COMPRESSED THE AORTA AT THE ROOT OF THE MESOCOLON AND ANESTHESIA PAUSED COMPRESSIONS AT WHICH POINT A PULSE WAS PRESENT. AT THIS TIME THE ON CALL VASCULAR SURGEON, DR. (B)(6), ARRIVED AND SCRUBBED IN. WE SEQUENTIALLY REMOVED THE LAPAROTOMY PADS. NO ACTIVE HEMORRHAGE WAS NOTED. THE SMALL BOWEL WAS REFLECTED INTO THE RIGHT UPPER QUADRANT AND WE INSPECTED THE PREVIOUS CAVAL REPAIR, AORTA AND ILIAC ARTERIES. NO HEMATOMA OR ACTIVE HEMORRHAGE WAS NOTED. THE PREVIOUS CAVAL REPAIR WAS INTACT AND HEMOSTATIC. WE RAN THE SMALL BOWEL AND INSPECTED THE SMALL BOWEL MESENTERY. A HEMATOMA WAS NOTED AT THE JEJUNAL MESENTERY ADJACENT TO THE ENTEROTOMY, BUT NO ACTIVE HEMORRHAGE WAS NOTED. I ASSISTED DR. (B)(6) AS HE EXPLORED THE MESENTERY OF THE SMALL BOWEL BUT NO ACTIVE HEMORRHAGE WAS NOTED, PLEASE SEE HIS OPERATIVE REPORT FOR MORE DETAIL." } ], "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": "" } ] }