{ "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": "2955842-2013-03703", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110506", "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": "20130920", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "473717", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130919", "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": "20250827", "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": "20130919", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "66", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Anemia", "Headache", "Low Blood Pressure/ Hypotension", "Pain", "Tachycardia", "Blood Loss", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20130820", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358978", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120820", "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": "3923211", "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 TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH LYSIS OF ADHESIONS ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF CHRONIC PELVIC PAIN, CHRONIC BACK PAIN, AND AN ENLARGED UTERUS. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI SURGICAL PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE PROCEDURE. AFTER LYSIS OF ADHESIONS WAS PERFORMED BY THE SURGEON, COPIOUS IRRIGATION OF THE PELVIS WAS RE-PERFORMED AND THE PELVIS WAS AGAIN NOTED TO BE HEMOSTATIC. THE SURGEON STATED THAT AFTER THE UTERUS WAS REMOVED THROUGH VAGINA WITHOUT DIFFICULTY, THE PELVIS WAS COPIOUSLY IRRIGATED AND FOUND TO BE HEMOSTATIC. THE PATIENT'S VAGINAL CUFF WAS THEN CLOSED WITH A V-LOC SUTURE IN A RUNNING FASHION. THE PATIENT WAS EXTUBATED WITHOUT DIFFICULTY. SHE WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. POST-OPERATIVELY, THE PATIENT WAS FOUND TO BE ACUTELY HYPOTENSIVE WITH ACUTE BLOOD LOSS ANEMIA. ALTHOUGH THE PATIENT HAD ADEQUATE URINE OUTPUT, SHE REMAINED HYPOTENSIVE WITH INCREASING PAIN AND TACHYCARDIA. THE PATIENT WAS THEN TAKEN BACK TO THE OR FOR AN EXPLORATORY LAPAROTOMY. THE PATIENT VERBALLY CONSENTED ON THE RISKS AND BENEFITS OF THE PROCEDURE AND AN ARTERIAL LINE WAS PLACED. THE EXPLORATORY LAPAROTOMY REVEALED HEMOPERITONEUM, 3-4 ACTIVE PUMPING BLEEDERS AROUND THE VAGINAL CUFF AND ANTERIOR TO THE BLADDER, AND NEW LESIONS ON THE BLADDER. THE SURGEON UTILIZED 0 VICRYL TO SUTURE LIGATE THE VESSELS. AN ARGON BEAM WAS USED TO COAGULATE DIFFUSE BLEEDING FOUND ALONG THE BLADDER EDGE. LARGE AMOUNTS OF CLOTS WERE EVACUATED FROM THE UPPER ABDOMEN. THE ABDOMEN WAS IRRIGATED COPIOUSLY AND FOUND TO BE HEMOSTATIC. GELFOAM WAS THEN PLACED AT THE VAGINAL CUFF. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE PACU INTUBATED. DURING THE COURSE OF THE HOSPITALIZATION, THE PATIENT RECEIVED LARGE AMOUNTS OF BLOOD PRODUCT AND VOLUME SUPPLEMENTATION. ACCORDING TO THE GYN PROGRESS NOTES FROM (B)(6) 2011, THE PATIENT HAD REPORTED COMPLAINTS OF ABDOMINAL PAIN AND A MIGRAINE HEADACHE. BASED ON THE GYN PROGRESS NOTE FOR (B)(6) 2011, THE PATIENT'S VITALS WERE STABLE AND SHE WAS FEELING BETTER. HER PAIN WAS WELL CONTROLLED. HER FOLEY CATHETER WAS OUT AND SHE WAS VOIDING INDEPENDENTLY WITH GOOD URINE OUTPUT. THE PATIENT WAS ABLE TO PASS AMPLE FLATUS AND SHE WAS NOTED TO HAVE IMPROVEMENT WITH ABDOMINAL DISTENSION. NO ADDITIONAL MEDICAL CHART INFORMATION WAS PROVIDED AFTER THE GYN PROGRESS NOTE SINCE (B)(6) 2011." }, { "mdr_text_key": "11230581", "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 FOR THE POST-OPERATIVE 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY." } ], "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": "" } ] }