{ "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": "2955842-2012-00444", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120914", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120729", "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": "20120917", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120914", "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 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20120914", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Internal Organ Perforation" ] } ], "distributor_city": "", "date_report": "20120823", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2746266", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120823", "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": "3111774", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT'S BLADDER WAS PUNCTURED WITH A NEEDLE. THE AFFECTED AREA WAS REPAIRED AND THE PATIENT IS REPORTED TO HAVE RECOVERED OK. REPORTEDLY, DAMAGE TO THE PATIENT'S BLADDER WAS UNRELATED TO THE DA VINCI SI SYSTEM, INSTRUMENT AND/OR ACCESSORIES." }, { "mdr_text_key": "10177278", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2012, ISI CONTACTED (B)(4), THE RISK MANAGER AT (B)(6) HOSPITAL AND HE INDICATED THAT APPROXIMATELY 4 OR 5 DAYS POST A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT MET WITH HER PRIMARY CARE PHYSICIAN (PCP) AND DURING HER EXAMINATION, THE PATIENT INDICATED TO THE PCP THAT SHE WAS EXPERIENCING ABDOMINAL PAIN AND A CATHETER WAS PLACED. (B)(6) INDICATED THAT LATER THAT DAY THE PATIENT WAS ADMITTED INTO GOOD (B)(6)'S EMERGENCY ROOM DUE TO EXPERIENCING ABDOMINAL PAIN AND THAT AN EXPLORATORY LAPAROSCOPIC PROCEDURE REVEALED THAT THE PATIENT'S BLADDER WAS DAMAGED. (B)(6) INDICATED THAT THE PATIENT'S BLADDER WAS REPAIRED THAT SAME DAY USING TRADITIONAL LAPAROSCOPIC TECHNIQUES. (B)(6) INDICATED THAT IT IS THE HOSPITAL'S BELIEF THAT DAMAGE TO THE PATIENT'S BLADDER OCCURRED WHILE THE SURGEON WAS SUTURING THE PATIENT'S VAGINAL CUFF. JIM INDICATED THAT DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE, NO INTRA OPERATIVE COMPLICATIONS WERE EXPERIENCED BY THE PATIENT AND THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. (B)(6) INDICATED THAT (B)(6) HAD THEIR DA VINCI SI SYSTEM EVALUATED BY A THIRD PARTY COMPANY; HOWEVER, HE INDICATED THAT THE EVALUATION RESULTS ARE NOT AVAILABLE. (B)(6) INDICATED THAT IT IS UNKNOWN IF A VIDEO RECORDING OF THE PLANNED SURGICAL PROCEDURE IS AVAILABLE AND THAT HE IS UNABLE TO PROVIDE ISI WITH COPIES OF THE PATIENT'S OPERATIVE REPORT DUE TO HIPPA REGULATIONS. ISI EXPLAINED TO (B)(6) THAT HIPPA REGULATIONS ARE NOT APPLICABLE TO ADVERSE EVENTS; HOWEVER, (B)(6) INDICATED THAT HE DID NOT FEEL COMFORTABLE PROVIDING THIS INFORMATION AND (B)(6) WILL RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION DIRECTLY FROM THE FDA. ON (B)(4) 2012, AN ISI FIELD SERVICE ENGINEER (FSE) WAS PRESENT DURING EVALUATION OF THE SITE'S DA VINCI SURGICAL SYSTEM BY THE THIRD PARTY COMPANY TO PROVIDE GENERAL INFORMATION CONCERNING THE FUNCTIONALITY OF THE SYSTEM. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL AND THE SITE HAS CONTINUED TO PERFORM SURGICAL PROCEDURES USING THEIR DA VINCI SI SURGICAL SYSTEM." } ], "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": "" } ] }