{ "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": "2955842-2014-03944", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140626", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140515", "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": "20140627", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "374938", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140626", "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": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20140626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Fever", "Internal Organ Perforation", "Test Result" ] } ], "distributor_city": "", "date_report": "20140527", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3898260", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140527", "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": "12144461", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ACCORDING TO THE SITE'S DIRECTOR OF SURGICAL SERVICES, THE PATIENT'S INTRA-OPERATIVE BLADDER INJURY WAS CAUSED BY SURGEON ERROR. ACCORDING TO THE SITE'S DIRECTOR OF SURGICAL SERVICES, THE PATIENT'S POST-OPERATIVE COMPLICATION WAS UNRELATED TO ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. AN ISI STERILE REPROCESSING SPECIALIST PERFORMED A FIELD EVALUATION AT THE SITE AND DID NOT FIND ANY ISSUES WITH THE SITE'S STERILIZATION PROCESS OF THE INSTRUMENTS. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014 AND NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A BLADDER INJURY WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USER-ERROR BY THE SURGEON." }, { "mdr_text_key": "4673168", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE SURGEON NOTICED A SLIGHT HOLE IN THE PATIENT'S BLADDER. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGERY LASTED ABOUT 1 HOUR AND 40 MINUTES. THE PATIENT WAS READMITTED ON (B)(6) 2014 AND WAS FOUND TO HAVE A PELVIC ABSCESS. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. A FEW DAYS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE WAS COMPLETED, THE PATIENT RETURNED TO THE HOSPITAL AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS FOUND TO HAVE A PELVIC ABSCESS, HIGH FEVER, AND AN ELEVATED WHITE BLOOD CELL (WBC) COUNT. NO ADDITIONAL POST-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S DIRECTOR OF SURGICAL SERVICES. ACCORDING TO THE DIRECTOR OF SURGICAL SERVICES, THE BLADDER INJURY WAS CAUSED BY SURGEON ERROR AND WAS SUCCESSFULLY REPAIRED BY THE SURGEON USING 2-3 STITCHES DURING THE DA VINCI HYSTERECTOMY PROCEDURE. SHE ALSO STATED THAT THE BLADDER INJURY WAS NOT CAUSED BY A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND WAS UNRELATED TO THE POST-OPERATIVE INFECTION EXPERIENCED BY THE PATIENT. IN REGARDS TO THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT, THE DIRECTOR OF SURGICAL SERVICES INDICATED THAT THE SITE PERFORMED AN INTERNAL INVESTIGATION AND IT WAS DETERMINED THAT THE INFECTION WAS NOT CAUSED BY ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. AN ISI STERILE REPROCESSING SPECIALIST PERFORMED A FIELD EVALUATION AT THE SITE AND DID NOT FIND ANY ISSUES WITH THE SITE'S STERILIZATION PROCESS OF THE INSTRUMENTS. THE DIRECTOR OF SURGICAL SERVICES STATED THAT SUBSEQUENT DA VINCI SURGICAL PROCEDURES WERE PERFORMED ON THE SAME DA VINCI SYSTEM AND BY THE SAME SURGEON INVOLVED WITH THIS COMPLAINT AND NO RECURRENCES OF POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED." } ], "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": "" } ] }