{ "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": "2026-09-22", "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": "2955842-2013-03166", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111206", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409759", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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 A6.0P6", "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": [ "Device Dislodged or Dislocated" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Fatigue", "Fever", "Fistula", "Unspecified Infection", "Pain", "Stenosis", "Obstruction/Occlusion", "Hematuria" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305703", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3711432", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT DEVELOPED A URETERAL VAGINAL FISTULA AS A RESULT OF THE SURGICAL PROCEDURE. THE LEGAL CLAIMS ALSO ALLEGED THAT THE PATIENT SUSTAINED KIDNEY DAMAGE THAT WAS CAUSED BY A SERIES OF INFECTIONS SHE CONTRACTED DURING HER POST-SURGICAL STRUGGLES. ADDITIONALLY IT WAS STATED THAT THE PATIENT HAD AN UNREMARKABLE MEDICAL HISTORY BUT HAD BEEN DEALING WITH MENORRHAGIA. PRIOR TO UNDERGOING THE HYSTERECTOMY, THE PATIENT DID NOT HAVE ANY PROBLEMS WITH HER KIDNEYS, URETERS, OR BLADDER. THE OPERATIVE REPORT INDICATED THAT DURING THE DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT HAD EXTENSIVE LYSIS OF ADHESIONS AND BILATERAL OVARIAN CYSTECTOMY. AFTER THE PATIENT'S VAGINAL CUFF WAS CLOSED, THE PATIENT WAS GIVEN 5 CC INDIGO CARMINE DYE INTRAVENOUSLY AND CYSTOSCOPY WAS THEN PERFORMED. THE OPERATIVE REPORT STATES THAT THE PATIENT'S RIGHT URETERAL ORIFICE DID NOT HAVE ANY FLOW AFTER OVER 40 MINUTES OF OBSERVATION. A UROLOGIST WAS THEN CONSULTED. THE UROLOGIST OBSERVED NARROWING OF THE PATIENT'S RIGHT URETER AND SOME MILD HYDROURETERONEPHROSIS. THE UROLOGIST IMPLANTED A URETERAL STENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2011. THE PATIENT'S MEDICAL RECORDS STATE THAT THE PATIENT WAS SEEN BY THE SURGEON ON (B)(6) 2011. THE SURGEON INFORMED THE PATIENT THAT THE RIGHT FLANK PAIN SHE HAD EXPERIENCED OVER THE PREVIOUS SEVERAL MONTHS MIGHT HAVE BE RELATED TO POSSIBLE CONGENITAL URETERAL STRICTURE. ON (B)(6) 2011, THE PATIENT WAS EVALUATED DUE TO COMPLAINTS OF INCREASING RIGHT FLANK PAIN. THE PATIENT COMPLAINED OF FATIGUE, LOW GRADE FEVER, AND HEMATURIA STARTING THE DAY BEFORE. IVP SHOWS A HIGH GRADE OBSTRUCTION ON THE RIGHT HAND SIDE WITH STENOSIS. ACCORDING TO THE UROLOGIST'S NOTES, THIS COULD BE A STRICTURE THAT IS BLOCKING THIS URETER. THE PATIENT UNDERWENT ANOTHER CYSTOSCOPY IN ADDITION TO A RIGHT URETEROSCOPY AND URETERAL DILATION ON (B)(6) 2011. ANOTHER URETERAL STENT WAS PLACED THAT SAME DAY. AN X-RAY PERFORMED THAT DAY REVEALED THAT THE PATIENT HAD A RIGHT URETERAL STRICTURE AND A QUESTIONABLE URETEROVAGINAL FISTULA ON (B)(6) 2012, THE PATIENT CAME TO SEE THE DOCTOR BECAUSE THE STENT FELL OUT. THE PATIENT UNDERWENT ANOTHER CYSTOSCOPY, A RIGHT URETEROSCOPY, A RIGHT RETROGRADE AND LASER OF URETEROVAGINAL FISTULA, AND PLACEMENT OF ANOTHER STENT. ON (B)(6) 2013 THE PATIENT VISITED THE DOCTOR AND THE STENT WAS REMOVED THE SAME DAY. ON (B)(6) 2013 THE PATIENT UNDERWENT A RIGHT DISTAL URETERAL RE-IMPLANTATION USING A PSO AS HITCH AND MOBILIZING / PEXING OF THE RIGHT OVARY. THE PATIENT WAS DISCHARGED ON (B)(6) 2013." }, { "mdr_text_key": "11074558", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE DOCUMENTATION RECEIVED ALLEGED THAT THE PATIENT SUSTAINED A URETERAL VAGINAL FISTULA AS A RESULT OF UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURY OCCURRED AND IF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "" } ] }