{ "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": "2955842-2013-04823", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "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": [ "Health Professional", "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "560147", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYS., INSTRUMENTS, ACCESSORIES & ESU." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441162", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "3900087", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED A BILE DUCT INJURY. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL TO OPEN TECHNIQUES TO REPAIR AND COMPLETE THE SURGICAL PROCEDURE." }, { "mdr_text_key": "11249328", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, HE WAS TAKING DOWN THE PATIENT'S GALL BLADDER WHEN THE DAMAGE TO THE PATIENT'S BILE DUCT OCCURRED. THE INJURY TO THE PATIENT WAS IMMEDIATELY IDENTIFIED AND THE AFFECTED AREA WAS REPAIRED USING OPEN SURGICAL TECHNIQUES. THE SURGEON INDICATED THAT THE PATIENT'S GALL BLADDER WAS INFECTED AND WAS PLIABLE, MAKING IT DIFFICULT FOR HIM TO REMOVE THE ORGAN. THE SURGEON INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THAT THE INJURY TO THE PATIENT'S BILE DUCT WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, BUT OCCURRED DUE TO THE PATIENT'S DIFFICULT ANATOMY. THE SURGEON STATED THAT IT WAS UNKNOWN WHICH INSTRUMENT INTRODUCED THE DAMAGE TO THE PATIENT'S BILE DUCT. ACCORDING TO THE SURGEON, THE PATIENT TOLERATED THE OPEN PROCEDURE AND RECOVERED WELL. HOWEVER, APPROXIMATELY 4 TO 6 WEEKS LATER IT WAS DISCOVERED THAT THE PATIENT HAD STONES IN HER BILE DUCT, REQUIRING THE PATIENT TO UNDERGO AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO REMOVE THE STONES. NO OTHER INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BILE DUCT INJURY DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE. BASED ON THE INFORMATION PROVIDED BY THE SURGEON, IT HAS BEEN DETERMINED THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE INJURY SUSTAINED BY THE PATIENT. PER THE INFORMATION PROVIDED BY THE SURGEON THE INJURY TO THE PATIENT OCCURRED DUE TO THE PATIENT'S DIFFICULT ANATOMY." } ], "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": "" } ] }