{ "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": "2955842-2013-03706", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120906", "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": "472280", "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": "20250811", "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": [ "Required Intervention" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Internal Organ Perforation", "Discomfort" ] } ], "distributor_city": "", "date_report": "20130820", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358980", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130820", "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": "3933505", "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 SUPRACERVICAL HYSTERECTOMY WITH REMOVAL OF A RIGHT PELVIC MASS ON (B)(6) 2012. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF UTERINE FIBROIDS, DYSMENORRHEA, MENOMETRORRHAGIA, AND PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT DUE TO THE SIZE OF THE UTERUS THERE WAS DIFFICULTY VISUALIZING CLEARLY. AFTER THE UTERINE VESSELS AND BROAD LIGAMENT WERE SKELETONIZED AND DISSECTED OUT, THE SURGEON STATED THAT THE LEFT URETER WAS DESICCATED AND LIGATED. IN ADDITION, AFTER THE UTERUS WAS EXCISED OFF THE CERVIX AND THE CERVICAL STUMP WAS APPROXIMATED, THE SURGEON STATED IN THE OPERATIVE REPORT THAT ENTRY INTO THE BLADDER WAS NOTED. AFTER THE CYSTOTOMY WAS REPAIRED WITH 3-0 VICRYL SUTURES, A DIAGNOSTIC CYSTOSCOPY WAS PERFORMED AND NO EFFLUX WAS OBSERVED FROM THE LEFT URETER. A UROLOGY SURGEON ATTEMPTED UNSUCCESSFULLY TO PLACE A STENT INTO THE LEFT URETER. THE UROLOGY SURGEON THEN PROCEEDED TO REIMPLANT THE LEFT URETER TO THE BLADDER. THE UROLOGY SURGEON ALSO PLACED A DOUBLE-J STENT. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF LOWER ABDOMINAL PAIN AND LEAKING OF URINE AROUND THE FOLEY CATHETER. THE PATIENT WAS FOUND TO HAVE URINARY RETENTION. THE FOLEY CATHETER WAS FLUSHED AND A LARGE VOLUME OF URINE THEN CAME OUT THROUGH THE CATHETER. THE PATIENT REPORTEDLY FELT IMMEDIATE RELIEF OF HER PAIN AND PRESSURE SENSATION. THE PATIENT WAS DISCHARGED HOME THAT SAME DAY WITH A PLAN FOR A CYSTOSCOPY TO BE PERFORMED THE FOLLOWING FRIDAY. NO ADDITIONAL MEDICAL CHARTS WERE PROVIDED FOLLOWING THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2012." }, { "mdr_text_key": "11230582", "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 INTRA-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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED INJURIES TO HER LEFT URETER AND URINARY BLADDER DURING A DA VINCI SI SURGICAL 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": "" } ] }