{ "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": "2955842-2013-03503", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121205", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458839", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "81", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Nausea", "Thrombus", "Vomiting" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345269", "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": "21875096", "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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF IRREGULAR BLEEDING AND PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. AFTER THE PATIENT'S UTERUS, OVARIES, AND TUBES WERE REMOVED THROUGH THE VAGINA, THE VAGINAL CUFF WAS CLOSED WITH SUTURES AND CAREFUL INSPECTION REVEALED EXCELLENT HEMOSTASIS OF ALL PEDICLES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, AND VOMITING. THE PATIENT WAS SENT HOME THE SAME DAY AFTER NO SIGNS OF ACUTE INTRA-ABDOMINAL OR PELVIC ABSCESSES WERE FOUND. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN THE ER FOR REPORTED COMPLAINTS OF VAGINAL BLEEDING, NAUSEA, AND VOMITING. A CT SCAN PERFORMED ON THE PATIENT REVEALED NO EVIDENCE OF FLUID COLLECTION, ABSCESSES, OR HEMATOMAS. THE ATTENDING PHYSICIAN NOTED IN THE PATIENT'S MEDICAL RECORDS THAT THE BLEEDING WAS NORMAL AND WAS MOST LIKELY COMING FROM THE SUTURES ABSORBING AT THE VAGINAL CUFF. THE PHYSICIAN ALSO NOTED THAT THE VAGINAL CUFF WAS INTACT. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED TO THE ER AND WAS EVALUATED AGAIN FOR A REPORTED COMPLAINT OF VAGINAL BLEEDING SECONDARY TO HYPOTENSION. THE PATIENT WAS FOUND TO HAVE LOOSENED SUTURES ALONG THE VAGINAL CUFF WITH ABOUT A 50 ML CLOT LOCATED IN THE VAGINA. THAT SAME DAY, THE PATIENT WAS TAKEN TO THE OPERATING ROOM, GENERAL ANESTHESIA WAS ADMINISTERED, AND THE VAGINAL CUFF WAS REPAIRED WITH SUTURES. SHE WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY ON (B)(6) 2012. ON (B)(6) 2013, THE PATIENT RETURNED TO THE ER WITH A REPORTED COMPLAINT OF VAGINAL BLEEDING. UPON EVALUATION, THE PATIENT WAS FOUND TO HAVE A SMALL BLOOD VESSEL BLEEDING AT THE VAGINAL CUFF. THE PATIENT THEN UNDERWENT A SURGICAL PROCEDURE FOR REVISION OF THE VAGINAL CUFF. SHE WAS DISCHARGED HOME ON (B)(6) 2013." }, { "mdr_text_key": "21888467", "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 REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AFTER UNDERGOING A DA VINCI SI 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": "" } ] }