{ "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": "2955842-2013-03553", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130913", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110627", "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": "20130916", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "461475", "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": "DA", "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": [ "Defective Device" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "20130913", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fistula", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Peritonitis", "Injury" ] } ], "distributor_city": "", "date_report": "20130904", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3348073", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130904", "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": "3864414", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2011 FOR SEVERE MENORRHAGIA WITH FIBROIDS. THE OPERATIVE REPORT FOR THE DA VINCI SI PROCEDURE WAS NOT PROVIDED; HOWEVER, MEDICAL RECORDS FROM FOLLOW UP VISITS INDICATE THAT THE PATIENT DID NOT SUSTAIN ANY APPARENT INTRAOPERATIVE INJURY. PATIENT WAS DISCHARGED THE NEXT DAY. ON (B)(6) 2011, THE PATIENT REPORTED INCREASING ABDOMINAL PAIN AND PRESENTED TO THE EMERGENCY ROOM. SHE UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND INTRA-ABDOMINAL WASHOUT FOR POST-OPERATIVE PERITONITIS WITH PELVIC HEMATOMA. LATER THE SAME MONTH, THE PATIENT RECEIVED A RIGHT URETERAL STENT FOR RIGHT URETEROVAGINAL FISTULA. IN (B)(6) 2011, A CYSTOSCOPY REVEALED THAT THE URETEROVAGINAL FISTULA HAS HEALED AND THE STENT WAS REMOVED. IN NOVEMBER 2012, THE PATIENT HAD COMPLAINTS OF POST COITAL BLEEDING WITH NO PAIN. IN (B)(6) 2012, THE PATIENT UNDERWENT A REVISION OF VAGINAL CUFF FOR A SMALL VAGINAL CUFF DEFECT. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." }, { "mdr_text_key": "11179682", "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 MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI HAS 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) 2011 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." }, { "mdr_text_key": "23095807", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 09/04/2013, ISI RECEIVED ADDITIONAL MEDICAL RECORDS RELATED TO THE PATIENT'S DA VINCI SI HYSTERECTOMY PROCEDURE THAT OCCURRED ON (B)(6) 2011. PER THE MEDICAL RECORDS, THE PATIENT WAS ADMITTED ON (B)(6) 2011 AND DISCHARGED ON (B)(6) 2011. THE PATIENT UNDERWENT THE HYSTERECTOMY PROCEDURE FOR HER PROBLEMS WITH FIBROID UTERUS, DYSMENORRHEA, AND MENORRHAGIA. THE ONSET OF HER PROBLEMS STARTED SEVERAL YEARS PRIOR TO HER HYSTERECTOMY PROCEDURE. THE RISKS OF THE SURGERY WERE DISCUSSED WITH THE PATIENT, INCLUDING BUT NOT LIMITED TO INFECTION, BLEEDING, DAMAGE TO INTERNAL ORGANS, ANESTHESIA COMPLICATIONS, BLOOD CLOTS, DEATH, FAILURE OF THE SURGERY, POSSIBLE NEED FOR FUTURE SURGERIES, OR NEED TO CONVERT TO OPEN PROCEDURE. TO THIS DATE, THE DA VINCI SI HYSTERECTOMY PROCEDURE HAS NOT BEEN PROVIDED WITH THE MEDICAL RECORDS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA." } ], "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": "09/20/2013" } ] }