{ "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": "2955842-2014-01652", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140320", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120713", "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": "20140321", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "167616", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140320", "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": [ "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20140320", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "112", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence" ] } ], "distributor_city": "", "date_report": "20140218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3691262", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140218", "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": "4255954", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4). PER THE REPORT, PATIENT HAD ELECTIVE SALPINGO-OOPHORECTOMY; FOUR WEEKS POST-OP THE PATIENT HAD SYMPTOMS OF UNCONTROLLABLE URINE LEAKAGE. ADDITIONAL SURGERY WAS PERFORMED TO REPAIR THE VAGINAL CUFF, VAGINAL FISTULA AND STENT THE LEFT URETER. ON (B)(4) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT'S PRE-OPERATIVE DIAGNOSIS PRIOR TO UNDERGOING THE DA VINCI SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 WAS PELVIC PAIN, LEFT OVARIAN CYST, AND ABNORMAL UTERINE BLEEDING. THE PROCEDURE FINDINGS WERE LEFT HYDROSALPINX, SOME OOZING NOTED ALONG RIGHT PELVIC SIDEWALL. AT THE CONCLUSION OF THE DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. SHE WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1 ((B)(6) 2012). ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTO, ATTEMPTED RETROGRADE PROCEDURE FOR COMPLAINTS OF UNCONTROLLABLE URINE LEAKAGE, URINARY INCONTINENCE, AND INCREASED VAGINAL BLEEDING. THE PROCEDURE FINDINGS INCLUDING A 1 CM LESION CEPHALAD, SLIGHTLY LATERAL TO LEFT ORIFICE THAT HAD SOME MUCOSAL EDEMA. AT THE END OF THE SURGICAL PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 2 ((B)(6) 2012). ACCORDING TO THE RISK MANAGEMENT DEPARTMENT, THE SITE WAS UNCERTAIN IF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "11619974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S POST-OPERATIVE COMPLICATIONS. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SALPINGO-OOPHORECTOMY PROCEDURE. HOWEVER, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN." } ], "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": "" } ] }