{ "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": "2955842-2013-03457", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130910", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120612", "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": "20130911", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "452974", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130910", "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": "IS 3000 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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130910", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "34 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Cyst(s)", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Swelling", "Thrombosis", "Tissue Damage", "Loss of consciousness" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3340352", "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": "3807444", "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, INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND DEVELOPED POST-OPERATIVE COMPLICATIONS. ON (B)(6) 2012, THE PATIENT WAS ADMITTED FOR PERSISTENT DYSFUNCTIONAL UTERINE BLEEDING, PERSISTENT PELVIC PAIN, DYSMENORRHEA AND PROBABLE ADENOMYOSIS. THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE WITH PRESERVATION OF THE OVARIES ON (B)(6) 2012. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WAS NO INDICATION IN THE OPERATIVE REPORTS THAT A MALFUNCTION OCCURRED WITH THE DA VINCI SYSTEM OR INSTRUMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 IN SATISFACTORY CONDITION. ON (B)(6) 2012, THE PATIENT CONTACTED THE HOSPITAL WITH COMPLAINT OF PASSAGE OF SOME RED TISSUE IN A SMALL CLUMP. SHE HAD NO ACTIVE BLEED AT THAT TIME. SEVERAL HOURS LATER HER BLEEDING WAS HEAVY AND SHE WAS ADVISED TO COME INTO THE ER. SHE WAS TRANSFERRED TO THE HOSPITAL AND UPON ARRIVAL; THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH HYPOTENSION, UNRESPONSIVENESS AND PERSISTENTLY HEAVY VAGINAL BLEEDING. ULTRASOUND WAS PERFORMED AND REVEALED AN 8X6CM CLOT AND FLUID WITHIN THE PELVIS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE AN EXPLORATORY MINI LAPAROTOMY WITH CAUTERIZATION OF RIGHT HEMORRHAGIC CORPUS LUTEUM CYST, LYSIS OF ADHESIONS, OVER SEWING IF THE VAGINAL CUFF AND BIMANUAL EXAM WAS PERFORMED ON (B)(6) 2012. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON POSTOPERATIVE DAY 1 WITH A FOLLOW UP APPOINTMENT WITHIN 1-2 WEEKS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT CONDITION." }, { "mdr_text_key": "11091190", "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 COMPLAINTS WAS REPORTED RELATING TO THIS EVENT, ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012 AND NO MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. 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." } ], "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": "" } ] }