{ "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": "2955842-2014-00360", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140121", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131218", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140122", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "50371", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140121", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "NH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20140121", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20131218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3582932", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131218", "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": "4032133", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON MADE AN INCISION INTO THE PATIENT'S BLADDER WHICH WAS ADHERED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE INCISION WAS CREATED WHILE THE SURGEON WAS PERFORMING A COLPOTOMY. THE BLADDER INJURY WAS RECOGNIZED AND REPAIRED BY A UROLOGIST. THE UROLOGIST NOTED NORMAL FUNCTION OF BOTH URETHRAL SPHINCTERS WITH THE USE OF DYE AND THE BLADDER DEFECT WAS CLOSED WITH SUTURES. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS DOING OK POST-OPERATIVELY. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED THAT THE BLADDER INJURY WAS DUE TO A SURGICAL ERROR. ACCORDING TO THE INITIAL REPORTER, THE SURGEON DID NOT REALIZE THAT THE BLADDER WAS STILL ADHERED AND INADVERTENTLY CREATED A NICKEL SIZED INCISION IN THE PATIENT'S BLADDER. THE INITIAL REPORTER ALSO STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER INDICATED THAT A DRAIN WAS PLACED DURING THE REPAIR AND WAS REMOVED ON POST-OP DAY 1 OR 2. THE PATIENT WAS DISCHARGED AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "11417648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. ISI HAS MADE SEVERAL ATTEMPTS 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) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BLADDER INJURY WHILE UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, ACCORDING TO THE INITIAL REPORTER, THE BLADDER INJURY WAS CAUSED BY SURGICAL ERROR." } ], "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": "" } ] }