{ "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": "2955842-2013-03548", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130913", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120109", "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": "20130913", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "462706", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130913", "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 A60.P8", "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": [ "Leak/Splash" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20130913", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Information" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3348017", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "16879206", "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, OF A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY AND CYSTOURETHROSCOPY PROCEDURE ON (B)(6) 2012. APPROPRIATE RISKS AND BENEFITS OF THE PROCEDURE WERE DISCUSSED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT'S PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSES WERE UTERINE FIBROIDS, PELVIC PAIN, MENORRHAGIA AND ANEMIA. THE UTERUS WAS INSPECTED AND FOUND TO BE TOO LARGE TO PASS THROUGH THE CUFF SO THE UTERUS WAS MORCELLATED USING THE GYNECARE DEVICE. THE FIBROIDS WERE TOO DENSE SO THE GYRUS MORCELLATOR WAS USED. THE PELVIS WAS IRRIGATED MULTIPLE TIMES AND MULTIPLE PIECES OF THE UTERUS WERE REMOVED. THE PROCEDURE FINDINGS WERE AN ENLARGED FIBROID UTERUS, BILATERAL OVARIAN CYSTS, AND A UTERUS MEASURING 1075 GRAMS. NO COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SI SYSTEM WERE NOTED IN THE OPERATIVE REPORT. APPROXIMATELY 12 DAYS AFTER THE DA VINCI SI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT SOUGHT MEDICAL ATTENTION BECAUSE THE PATIENT BEGAN EXPERIENCING UNCONTROLLABLE INCONTINENCE THE DAY PRIOR TO COMING IN. A PELVIC EXAM REVEALED NOTHING PARTICULARLY UNUSUAL ABOUT THE VAGINAL CUFF; HOWEVER, URINE WAS NOTED TO BE IN THE VAGINA. TESTS CONFIRMED THE FLUID WAS URINE. THE DOCTOR SUSPECTED THE PATIENT HAD A URETEROVAGINAL FISTULA AND REFERRED HER TO A UROLOGIST FOR A CYSTOSCOPY, RETROGRADE INTRAVENOUS PYELOGRAM, AND A STENT PLACEMENT. PER HER 6-WEEK POST-OPERATIVE EVALUATION ((B)(6) 2012), THE PATIENT HAD COMPLETED A WEEK FOR HER STENT PLACEMENT AND THE LEAKAGE HAS DECREASED DRASTICALLY. THE UROLOGIST'S REPORT WAS OPTIMISTIC ABOUT CLOSURE OF THE URETEROVAGINAL FISTULA WITH THE STENT ALONE. ABOUT A MONTH LATER ((B)(6) 2012), THE PATIENT HAD HER STENT REMOVED AND HAS NOT COMPLAINED ABOUT ANY LEAKAGES. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." }, { "mdr_text_key": "16966495", "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 OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL 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": "" } ] }