{ "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": "2955842-2013-04760", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111215", "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": "560484", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "brand_name": "DA VINCI SI 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": "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&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "41 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Deposits", "Fistula", "Incontinence" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3439857", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "18097944", "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": "17839739", "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 RADICAL HYSTERECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY FOR STAGE 1B SQUAMOUS CELL CARCINOMA OF THE CERVIX ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY, PREOPERATIVE H&P, SEVERAL CT RECORDS, PROCEDURE RECORDS, AND THE DISCHARGE SUMMARY FOR THE LAST SURGERY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE UTERUS WAS NOTED TO BE SMALL AND MOBILE. THE PERIRECTAL AND PERIVESICAL SPACES AND BLADDER FLAP WERE DEVELOPED WITH NO EVIDENCE OF DISEASE, AND NODAL DISSECTIONS WERE COMPLETED FROM THE BIFURCATIONS OF THE COMMON ILIAC ARTERIES TO THE CIRCUMFLEX VEIN AND FROM THE OBTURATOR SPACES. THE UTERINE ARTERIES WERE CAUTERIZED AND DIVIDED AND URETERS WERE DISSECTED OFF OF THE MEDIAL ASPECT OF THE PERITONEUM TO THE LEVEL OF THE BLADDER WITH BLUNT DISSECTION AND ELECTROCAUTERY WITH CARE TO PRESERVE THE BLOOD SUPPLY. THE UTEROSACRAL, AND CARDINAL LIGAMENTS WERE DIVIDED, THE VAGINA CIRCUMFERENTIALLY DIVIDED, AND THE UTERUS DELIVERED THROUGH THE VAGINA. OBTURATOR NERVES AND URETERS WERE REVISUALIZED AND NOTED TO BE UNHARMED. THE VAGINAL CUFF WAS CLOSED. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT PRESENTED WITH PERSISTENT VAGINAL LEAKAGE OF URINE AND WAS REFERRED FOR CYSTOGRAM. ON (B)(6) 2012 THE PATIENT HAD AN IVP, NO RECORDS AVAILABLE ON (B)(6) 2012 PATIENT RECEIVED PERCUTANEOUS URETERAL STENT PLACEMENT AND NEPHROLOGRAM WHICH DEMONSTRATED CONTRAST POOLING IN THE VAGINA FROM THE DISTAL LEFT URETER AND NO LEAKAGE FROM THE RIGHT. A DOUBLE-D STENT WAS LEFT IN PLACE ACROSS THE LEFT URETER. ON (B)(6) 2012 AN ABDOMINAL CT WAS PERFORMED, NO RECORDS AVAILABLE ON (B)(6) 2012 A COMPARISON CT WITH CONTRAST WAS PERFORMED FOR LEFT LOWER QUADRANT PAIN. FINDINGS WERE NO EVIDENCE OF LEAK, DECREASING SIZE OF A LEFT RETROPERITONEAL URINOMA (COMPARED TO (B)(6)) AND SLIGHTLY INCREASED LEFT HYDRONEPHROSIS AND NEPHROGRAPHIC ASYMMETRY CONCERNING FOR STENT MALFUNCTION. ON (B)(6) 2012 A CT GUIDED EXCHANGE OF THE DRAIN WAS PERFORMED AND SUCCESSFUL PLACEMENT OF A 10.2FR DRAIN. PATIENT WAS DISCHARGED WITH DRAIN INSTRUCTIONS. ON (B)(6) 2012 AN ABDOMINAL CT WITH CONTRAST WAS PERFORMED. FINDINGS WERE A STONE IN THE LEFT RENAL PELVIS, A PROPERLY POSITIONED STENT, AND EXISTENCE OF 3 CM LLQ LOCULATED COLLECTION CONTAINING AIR CONCERNING FOR RESIDUAL URINOMA OR ABSCESS. ON (B)(6) 2012 PATIENT UNDERWENT CYSTO, LEFT RPG, LEFT JJ STENT PLACEMENT NO RECORDS AVAILABLE. ON (B)(6) 2012 PATIENT UNDERWENT CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, LEFT DISTAL URETEROSCOPY, LEFT URETERAL INSTILLATION OF METHYLENE BLUE, PLACEMENT OF LEFT DOUBLE J URETERAL STENT WITH INTRAOPERATIVE FLUOROSCOPY FOR LEFT DISTAL URETHRAL VAGINAL FISTULA. ON (B)(6) 2012 PATIENT UNDERWENT OPEN LEFT URETERAL REIMPLANT WITH NO NOTED COMPLICATIONS. SHE WAS DISCHARGED HOME WITH FOLEY CATHETER AND ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER DISCHARGE." } ], "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": "" } ] }