{ "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": "2955842-2014-05361", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140911", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140812", "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": "20140912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562854", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140911", "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": [ "Difficult To Position", "Device Displays Incorrect Message" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20140911", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20140812", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4082464", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140812", "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": "21721950", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, THE SURGEON FELT AS THOUGH SHE DID NOT HAVE FULL RANGE OF MOTION WHEN THE INSTRUMENTS WERE FIRST INSTALLED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE RANGE OF MOTION RETURNED. HOWEVER, WHILE MOVING THE INSTRUMENTS, THE SURGEON FOUND AN ARTERY THAT WAS ALLEGEDLY NICKED BY A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ON (B)(6) 2014, THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO ENCOUNTERING SYSTEM ERRORS. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND NOTED THAT A SINGLE ERROR CODE 100 HAD OCCURRED DURING THE SURGICAL PROCEDURE. AN ERROR CODE 100 IS AN INFORMATIONAL FAULT THAT SIGNIFIES THAT AN UNEXPECTED SETUP JOINT (SUJ) MOVEMENT WAS DETECTED. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE PERFORMED A COMPLETE SYSTEM VERIFICATION AND NO TROUBLE WAS FOUND. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ACCORDING TO THE FSE, NO ERRORS REFERENCING AN INSTRUMENT WERE FOUND IN THE SYSTEM LOGS. ON (B)(4) 2014, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. AT THE BEGINNING OF THE PROCEDURE, THE SURGEON COMPLAINED THAT SHE DID NOT HAVE COMPLETE MOBILITY OF THE INSTRUMENTS. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF ADVANCED THE INSTRUMENTS FURTHER AND THEN THE SURGEON WAS ABLE TO GAIN MOBILITY OF THE INSTRUMENTS. THE SURGEON THEN PROCEEDED WITH THE SURGERY. AT ONE POINT, THE INITIAL REPORTER NOTICED THAT THE TIP OF THE MCS INSTRUMENT WAS OFF OF THE SCREEN TOWARDS THE BOTTOM LEFT AND WAS OUT OF THE FIELD OF VISION. WHEN THE SURGEON MOVED, THE CAMERA TO FIND THE TIP OF THE MCS INSTRUMENT, SHE FOUND THE INSTRUMENT HAD PUNCTURED THE ILIAC ARTERY. THE SURGEON IMMEDIATELY MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGERY IN ORDER TO REPAIR THE VESSEL INJURY. THE INITIAL REPORTER DID NOT KNOW HOW THE VESSEL WAS REPAIRED AND WHAT THE PATIENT'S CURRENT STATUS IS." }, { "mdr_text_key": "22146124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM INVOLVED WITH THIS COMPLAINT AND NO TROUBLE WAS FOUND. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED CUSTOMER FAILURE MODE. 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. ACCORDING TO THE SITE'S SYSTEM LOGS, THE MCS INSTRUMENT USED DURING THE REPORTED EVENT HAS BEEN USED IN 2 SUBSEQUENT DA VINCI SURGICAL PROCEDURES. NO MCS INSTRUMENT ISSUES WERE REPORTED TO ISI IN REGARDS IN RELATION TO THE 2 SUBSEQUENT DA VINCI SURGICAL PROCEDURES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON CLAIMED THAT THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED AND ONE OF THE PATIENT'S ARTERIES WAS NICKED BY AN MCS INSTRUMENT." } ], "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": "" } ] }