{ "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": "2955842-2013-04765", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20090511", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559959", "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": [ "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": "20250724", "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&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Fistula" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3439935", "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": "3860328", "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 CYSTOSCOPY WITH BILATERAL URETERAL TEMPORARY STENT PLACEMENT, DA VINCI RADICAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND LEFT OVARIAN SUSPENSION FOR AN INDICATION OF ADENOCARCINOMA OF THE CERVIX STATUS POST CONIZATION AND RIGHT ADNEXAL MASS PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND TWO SUBSEQUENT PROCEDURE REPORTS. NO MEDICAL HISTORY WAS AVAILABLE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. BEFORE SURGERY, THE SURGEON PERFORMED A CYSTOSCOPY AND TEMPORARY URETERAL STENT PLACEMENT. DURING SURGERY, THE SURGEON USED HOT SHEARS, FENESTRATED BIPOLAR GRASPER AND A PK DISSECTOR TO FIRST PERFORM A LYMPHADENECTOMY FROM THE COMMON ILIAC ARTERY TO THE CIRCUMFLEX VEIN AND THE OBTURATOR SPACE. THE UTERINE ARTERIES WERE ISOLATED, BIPOLAR CAUTERIZED, DIVIDED AND DISSECTED OVER THE URETERS, AND THE URETERS DISSECTED OFF OF THE MEDIAL PERITONEAL LEAVES, AND THE URETERAL TUNNELS BIPOLAR CAUTERIZED AND OPENED WITH COLD SCISSORS. THE UTEROSACRAL AND CARDINAL LIGAMENTS WERE SEQUENTIALLY BIPOLAR CAUTERIZED AND DIVIDED, THE COLPOTOMY CREATED WITH HOT SHEARS, AND THE INFUNDIBULOPELVIC LIGAMENT ON THE RIGHT SIDE BIPOLAR CAUTERIZED AND DIVIDED AND THE RIGHT OVARY REMOVED. THE UTERUS WAS REMOVED TRANSVAGINALLY, AND THE VAGINAL CUFF CLOSED AND THE SURGERY COMPLETED. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION, HOWEVER IT WAS NOTED THAT THE LEFT OVARY WAS ADHERENT TO THE SIGMOID SEROSA AND THERE WERE ADHESIONS IN THE PELVIS CONSISTENT WITH INFECTION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2009. ON (B)(6) 2009, PATIENT HAD CYSTOSCOPY AND BILATERAL RETROGRADE PYELOGRAMS AND A LEFT DOUBLE-J URETERAL STENT PLACED AFTER DEVELOPING A URETEROVAGINAL FISTULA AND HAVING A SUSPECTED PELVIC ABSCESS. RIGHT PYELOGRAM SHOWED NO ABNORMALITY, LEFT PYELOGRAM SHOWED EXTRAVASATION OF CONTRAST SEVERAL CENTIMETERS UP FROM THE URETERAL ORIFICE. A LEFT DOUBLE J STENT WAS PLACED. PATIENT WAS DISCHARGED ON (B)(6) 2009, BUT NO DISCHARGE SUMMARY WAS AVAILABLE. ON (B)(6) 2009, PATIENT UNDERWENT CYSTOSCOPY, LEFT RETROGRADE PYELOGRAPHY, URETEROSCOPY, BALLOON DILATION OF LEFT URETHRAL STRICTURE AND LEFT URETERAL STENT PLACEMENT FOR LEFT URETERAL OBSTRUCTION. THE NARROWING WAS OBSERVED 2 CM PROXIMAL TO THE INTRAMURAL TUNNEL, THEN DILATED AND A DOUBLE-J STENT PLACED. ON (B)(6) 2009, A CYSTOSCOPY AND RETROGRADE PYELOGRAM WERE PERFORMED FOR HISTORY OF LEFT URETERAL INJURY, AND THE LEFT URETER FOUND TO BE PERFECTLY DELINEATED WITH EQUAL CALIBER TO THE KIDNEY AND NO EVIDENCE OF HYDRONEPHROSIS. CLINICIAN SUSPECTS POOR FUNCTION OF URETER AND RECOMMENDED FOLLOW UP RENAL SCAN. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THIS DATE." }, { "mdr_text_key": "11395308", "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 PATIENT SUFFERED A URETER INJURY AFTER UNDERGOING A DA VINCI 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": "" } ] }