{ "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": "2955842-2013-04803", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110601", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559281", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": "", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "52 YR", "patient_sex": "", "patient_weight": "64", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Unspecified Infection", "Inflammation", "Swelling", "Obstruction/Occlusion", "Hematuria", "Dysuria" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440868", "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": "18098356", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." }, { "mdr_text_key": "17840239", "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 ROBOTIC TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR PERSISTENT POSTMENOPAUSAL VAGINAL BLEEDING ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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. PATIENT WAS NOTED TO HAVE NORMAL EXTERNAL ANATOMY. LAPAROSCOPIC VISUALIZATION OF THE ABDOMEN AND PELVIS NOTED PARAOVARIAN ADHESIONS CONSISTENT WITH OLD INFLAMMATORY DISEASE. IT WAS ALSO NOTED THAT THERE WERE A FILMY CULD-DE-SAC ADHESIONS. THE UTERUS WAS NOTED AS UNREMARKABLE. THE FALLOPIAN TUBES WERE NOTED AS DEMONSTRATING PRIOR LIGATION. THE PATIENT WAS PLACED IN STANDARD POSITIONING FOR HYSTERECTOMY. A FOLEY CATHETER AND V-CARE UTERINE MANIPULATOR WERE PLACED. THE VERRES NEEDLE WAS INSERTED INTRAPERITONEALLY THROUGH A 12MM EPIGASTRIC INCISION. ALL PORTS WERE PLACED UNDER DIRECT VISUALIZATION IN 15MMHG OF INSUFFLATION. THE PROCEDURE FLOW WAS AS FOLLOWS: -OPENING OF THE PERITONEUM OVERLYING THE RIGHT PELVIC SIDEWALL -WIDE DEVELOPMENT OF THE PERIVESICAL AND PERIRECTAL SPACES -CAUTERY TRANSECTION OF THE RIGHT ROUND LIGAMENT -ISOLATION, DESICCATION, AND TRANSECTION OF THE RIGHT INFUNDIBULOPELVIC VASCULATURE -DISSECTION OF THE POSTERIOR LEAF OF THE BROAD LIGAMENT TO THE CUL-DE-SAC -DISSECTION OF THE ANTERIOR LEAF OF THE BROAD LIGAMENT INFERIORLY CONTINUING ON AS THE VESICOUTERINE PERITONEUM. -BLADDER CAREFULLY DISSECTED INFERIORLY -REPEATED PROCEDURE ON THE LEFT -BILATERAL DESICCATION AND TRANSECTION OF THE UTERINE VASCULATURE -POSTERIOR COLPOTOMY INCISION WAS MADE AND CARRIED CIRCUMFERENTIALLY ABOUT THE CERVIX -THE HYSTERECTOMY SPECIMEN WAS DELIVERED TRANSVAGINALLY -THE VAGINAL CUFF WAS OVERSEWN WITH FIGURE-OF-EIGHT SUTURES OF 0-VYCRIL INCORPORATING THE UTEROSACRAL LIGAMENTS -THE PELVIS WAS NOTED TO BE ENTIRELY HEMOSTATIC -ESTIMATED BLOOD LOSS WAS NOTED AT 50CC WITH FLUID REPLACEMENT NOTED AT 1300CC. ON (B)(6) 2011 THE PATIENT HAD AN EXAM AS WHAT IS NOTED AS A RENAL FLOW AND FUNCTION STUDY FOR HISTORY OF RIGHT HYDRONEPHROSIS. IT WAS NOTED THAT A COMPARISON OF A CT FROM (B)(6) 2011 WAS PERFORMED AND MODERATE RIGHT HYDRONEPHROSIS AND HYDROURETER WAS FOUND. THE WORK UP DOES NOT NOTE WHEN THE HISTORY OF RIGHT HYDRONEPHROSIS WAS FIRST OBSERVED. THE RESULT OF THE EXAM NOTED RIGHT RENAL HYPOPERFUSION, MODERATE RIGHT HYDRONEPHROSIS, MILD RIGHT HYDROURETER WITH OBSTRUCTION MOST LIKELY IN PELVIS. THE LEFT RENAL PERFUSION AND FUNCTION WAS NOTED AS NORMAL. ON (B)(6) 2011 THE PATIENT UNDERWENT A CYSTOSCOPY WITH RIGHT RETROGRADE PYELOGRAM AND RIGHT URETERAL STENT PLACEMENT FOR RIGHT URETERAL OBSTRUCTION WITH HYDRONEPHROSIS. THE STENT PLACEMENT WAS NOTED IN GOOD POSITION AND THE KIDNEY DRAINED PROMPTLY. THERE WERE NO COMPLICATIONS NOTED. THE STENT WAS PLANNED TO BE REMOVED AFTER 3 MONTHS TIME WITH A FOLLOW UP RENAL SCAN. ON (B)(6) 2011 THE PATIENT HAD A CT OF THE ABDOMEN AND PELVIS WITHOUT IV CONTRAST FOR COMPLAINTS OF ABDOMINAL PAIN AND DYSURIA. THE IMPRESSION WAS NOTED THAT THE RIGHT URETERAL STENT WAS IN GOOD POSITION; THERE WERE MILD INFLAMMATORY CHANGES AROUND THE URETER AND RIGHT LOWER PELVIS. NO FLUID COLLECTIONS OR MASS LESIONS WERE IDENTIFIED. THE BLADDER WAS NOTED AS UNREMARKABLE. IT WAS NOTED THAT THERE WERE BILATERAL ILIAC ARTERY STENTS. ON (B)(6) 2100 THE PATIENT HAD HER STENT REMOVED AFTER REPORTING ANTICIPATED FLANK PAIN, DYSURIA AND HEMATURIA RELATED TO HER STENT. THIS WAS PERFORMED TRANS VAGINALLY. NO COMPLICATIONS NOTED. ON (B)(6) 2012 THE PATIENT HAD A FOLLOW UP CT OF THE ABDOMEN PELVIS WITH CONTRAST. THE IMPRESSION WAS NOTED AS IMPROVING RIGHT-SIDED HYDRONEPHROSIS AND HYDROURETER WITH NO LARGE FLUID COLLECTION IDENTIFIED. A STABLE TINY NODULAR FOCUS WITH IN THE LEFT LOWER LOBE WAS NOTED AS REPRESENTING A SMALL FOCUS OF INFECTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }