{ "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": "2955842-2013-05164", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131112", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130702", "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": "20131113", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "581179", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131112", "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", "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": "20250815", "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": "20131112", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Extravasation", "Abnormal Vaginal Discharge", "Injury", "Hematuria" ] } ], "distributor_city": "", "date_report": "20131015", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3465387", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131015", "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": "18150454", "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 MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "17955722", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR MENORRHAGIA AND UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND MEDICAL RECORDS RELATED TO A CYSTOSCOPY AND RETROGRADE PYELOGRAPHY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING SURGERY. ACCORDING TO THE DA VINCI OPERATIVE REPORT DATED (B)(6) 2013, THE PROCEDURE WAS NOTED TO BE AN EXTREMELY COMPLICATED CASE, WHICH TOOK ABOUT 4 HOURS AND AS NOTED TO TAKE 2-4 TIMES LONGER THAN NORMAL. THE PATIENT NOTABLY HAD A LARGE UTERUS THAT WEIGHED 650 GRAMS. SHE HAD 2 PREVIOUS C-SECTIONS, WHICH CAUSED SCARRING. THE PATIENT'S URETERS WERE UNDERNEATH A LOT OF SCAR TISSUE; THEREFORE, A CYSTOSCOPY WAS ALSO DONE BECAUSE OF THE COMPLICATED NATURE OF THE PROCEDURE, LYSIS OF SEVERE ADHESIONS WAS DONE AS THE PREVIOUS SURGEON WHO TRIED TO DO HER CHOLECYSTECTOMY COULD NOT EVEN GET INTO HER ABDOMINAL CAVITY. THE SURGEON WAS ABLE TO GET INTO THE PATIENT'S ABDOMINAL CAVITY AND LYSED THESE ADHESIONS. THE RIGHT SIDE OF THE PATIENT'S UTERUS WAS STUCK IN A LOT OF SCAR TISSUE FROM A PREVIOUS HYSTERECTOMY. THE VAGINAL CUFF WAS CLOSED AND A MORCELLATOR WAS USED ON THE UTERUS. A CYSTOSCOPY WAS PERFORMED DUE TO THE DIFFICULT ADHESIOLYSIS. IT WAS NOTED THAT INDIGO CARMINE CAME OUT OF BOTH URETERS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ACCORDING TO A BRIEF OPERATIVE NOTE DOCUMENT DATED (B)(6) 2013, THE INTRAOPERATIVE COMPLICATIONS ADDED MORE RISK TO THE PATIENT AND MAY ALSO INCREASE THE NEED FOR MORE PROLONGED POST-OPERATIVE CASE. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. THE PATIENT DID NOT HAVE ANY COMPLICATIONS BEFORE BEING DISCHARGED BUT WAS MADE AWARE OF POSSIBLE POST-OPERATIVE URINARY ISSUES. ON (B)(6) 2013, THE PATIENT UNDERWENT A SECOND PROCEDURE DUE TO VAGINAL LEAKAGE, HEMATURIA, AND POSSIBLE URETERAL INJURY. CYSTOSCOPY AND BILATERAL RETROGRADE PYELOGRAMS WERE PERFORMED. THE RIGHT URETER SHOWED EXTRAVASATION OF CONTRAST 5 CM FROM THE URETER'S OPENING INTO THE BLADDER. A NEPHROSTOMY TUBE WAS THEN PLACED TO DRAIN URINE OUT OF THE KIDNEY. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. NO FURTHER INFORMATION WAS PROVIDED." } ], "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": "" } ] }