{ "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": "2955842-2013-03516", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100127", "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": "459288", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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 S SURG SYS INST., ACCESSORIES, & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345902", "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": "3817255", "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 S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF MENORRHAGIA AND FIBROIDS. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI S HYSTERECTOMY, THE SURGEON STATED THAT ENDOMETRIOSIS AND FIBROIDS WERE FOUND AROUND THE LEFT SIDE OF THE BROAD LIGAMENT. THE SURGEON ALSO STATED THAT THE URETER WAS DIFFICULT TO SEE AND IN TRYING TO DISSECT OUT THE FIBROIDS FROM THE PREPERITONEAL SPACE, THE URETER WAS INADVERTENTLY TRANSECTED. UROLOGY WAS CALLED FOR ASSISTANCE. A FIBROID WAS FOUND EXTENDING AROUND THE URETER ON THE LEFT AND WAS REMOVED. AT THAT POINT, THE SURGEON MADE THE DECISION TO COMPLETE THE PROCEDURE AS A SUPRACERVICAL HYSTERECTOMY. AFTER COMPLETION OF THE HYSTERECTOMY, A SURGEON FROM UROLOGY MADE THE DECISION TO OPEN THE PATIENT FOR OPEN REANASTOMOSIS OF THE URETER INTO THE BLADDER. THE SURGEON PERFORMED A LEFT URETERAL RE-IMPLANT WITH STENT PLACEMENT. THE PATIENT'S FOLEY CATHETER WAS REMOVED ON (B)(6) 2010 AND HER STENT WAS REMOVED ON (B)(6) 2010. AN IVP WAS PERFORMED ON (B)(6) 2010 AND WAS FOUND TO BE NORMAL. EQUAL CONTRAST EXCRETION FROM BOTH KIDNEYS WAS OBSERVED AND NO EVIDENCE OF HYDRONEPHROSIS OR A URINARY TRACT INFECTION WAS FOUND. ON (B)(6) 2010, THE PATIENT UNDERWENT A RENAL ULTRASOUND AND THE KIDNEYS APPEARED NORMAL BILATERALLY WITH NO EVIDENCE OF HYDRONEPHROSIS. NO COMPLICATIONS WERE REPORTED DURING A FOLLOW-UP VISIT ON (B)(6) 2010." }, { "mdr_text_key": "11198983", "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. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED AFTER THE SURGICAL PROCEDURE WAS STARTED. 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 A URETERAL INJURY DURING A DA VINCI S 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": "" } ] }