{ "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": "2955842-2013-04903", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20081121", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "563157", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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 A6.0P7", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Tachycardia", "Weakness", "Dizziness" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444095", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "19591256", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY (>250G), ENTEROLYSIS, CYSTOURETHROSCOPY FOR MENORRHAGIA, FIBROIDS (18 WEEKS SIZE) AND PELVIC PAIN ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: GYN CONSULTATION IN ER ON (B)(6) 2008, OR REPORT ON (B)(6) 2008 AFTER PLACEMENT OF THE UTERINE MANIPULATOR AND INSTALLATION OF A PNEUMOPERITONEUM THROUGH A VERESS NEEDLE ADDITIONAL TROCARS WERE PLACED AND THE DAVINCI ROBOT DOCKED. ADHESIONS FROM THE SIGMOID COLON TO THE LEFT OVARY, POSTERIOR FUNDUS AND LEFT ABDOMINAL WALL WERE TAKEN DOWN SHARPLY AND FUNDAL ATTACHMENTS TO THE UTERUS, FALLOPIAN TUBES, UTERO-OVARIAN LIGAMENT AND ROUND LIGAMENTS WERE ELECTROCOAGULATED AND CUT. THE LEFT PEDICLE AND SIGNIFICANT BLADDER ADHESIONS WAS DISSECTED. THEN TRANSECTION OF THE BROAD LIGAMENT AND UTERINE VESSELS WAS PERFORMED. A SIMILAR PROCEDURE WAS PERFORMED ON THE OPPOSITE SIDE AND IDENTIFICATION OF A MASS THAT APPEARED AS A PEDUNCULATED FIBROID WAS NOTED. THIS WAS LATER ON RESECTED TRANSPERITONEALLY. AFTER BLADDER DISSECTION DOWN TO THE VAGINA, AN ANTERIOR COLPOTOMY WAS CARRIED OUT. BECAUSE OF THE SIZE OF THE UTERUS, THE BLADDER COULD NOT BE APPROACHED SAFELY AND THE LOWER UTERINE SEGMENT WAS TRANSECTED AND THE UPPER UTERUS LATER REMOVED TRANSABDOMINALLY. COLPOTOMY WAS COMPLETED AND REMOVAL OF THE LOWER UTERINE SEGMENT WITH THE CERVIX TRANSVAGINALLY WAS PERFORMED. VAGINAL CUFF CLOSURE WAS PERFORMED WITH VICRYL 0 IN A RUNNING INTERLOCKING STITCH. FIBROIDS WERE REMOVED TRANSABDOMINALLY WITH THE MORCELLATOR. METHYLENE BLUE WAS ADMINISTERED TO CONFIRM INTACT BILATERAL URETERS. SEPRAFILM WAS PLACED OVER THE CUFF. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. POSTOPERATIVELY, THE PATIENT EXPERIENCED SOME VAGINAL SPOTTING AFTER THE PROCEDURE THAT DECREASED UNTIL (B)(6) 2008 WHEN SHE WAS ADMITTED TO THE ER WITH PROFUSE VAGINAL BLEEDING, TACHYCARDIA, HYPOTENSION, DIZZINESS AND WEAKNESS. ON (B)(6) 2008: GYN CONSULTATION IN THE ER: ON EXAMINATION THE VAGINAL CUFF WAS OPEN AND ACTIVELY BLEEDING WITH A LARGE AMOUNT OF CLOT. ON (B)(6) 2008: THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS AND CLOSURE OF THE VAGINAL CUFF. INTRAABDOMINAL INSPECTION REVEALED A LARGE AMOUNT OF BLOOD CLOT AND BOWEL ADHESIONS TO THE CUFF AND LOWER PELVIS. ADHESIOLYSIS AND RE-CLOSURE OF THE VAGINAL CUFF WITH VICRYL 0 FIGURE-OF-EIGHT SUTURES WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE SECOND OPERATION." }, { "mdr_text_key": "19832130", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL 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": "" } ] }