{ "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": "I", "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": "2955842-2017-00713", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20171026", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20171002", "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": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171026", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "759418", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171026", "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 A60P9B", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "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": [ "Device Issue", "Device Issue" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20171026", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20171004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6982146", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171004", "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": "90395201", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CADIERE FORCEPS INSTRUMENT WAS DISCARDED BY THE SITE AND WILL NOT BE RETURNED TO ISI FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. ON 10/10/2017, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUES. THE FSE INSPECTED AND TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. THE SYSTEM LOGS THE SYSTEM LOGS ALSO REVEAL THAT A SYSTEM ERROR CODE 100 WAS GENERATED TWO TIMES DURING THE SURGICAL PROCEDURE. A SYSTEM ERROR CODE 100 IS AN INFORMATIONAL ERROR THAT IS GENERATED WHEN THE SYSTEM DETECTS THAT A SETUP JOINT WAS MOVED WHEN IT WAS NOT RELEASED. IT IS UNKNOWN IF THE SYSTEM ERROR CODE 100 WAS GENERATED IN RELATION TO THE ALLEGED ARM COLLISION(S) OR DURING THE ATTEMPTS TO REMOVE THE STUCK INSTRUMENT. THE SYSTEM LOGS ALSO REVEAL THAT THE CADIERE FORCEPS INSTRUMENT INVOLVED WITH THE REPORTED EVENT WAS USED DURING 5 SUBSEQUENT DA VINCI SURGICAL PROCEDURES. NO SUBSEQUENT COMPLAINTS INVOLVING THE CADIERE FORCEPS INSTRUMENT HAVE BEEN REPORTED TO ISI. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A SLIGHT NICK TO THE BOWEL MUCOSA THAT WAS REPAIRED WITH STITCHES. THE BOWEL INJURY ALLEGEDLY OCCURRED DURING ATTEMPTS TO REMOVE A CADIERE FORCEPS INSTRUMENT THAT WAS STUCK ON A ROBOTIC ARM. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE CUSTOMER REPORTED ISSUE AND INTRA-OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "90395202", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE ROBOTIC ARMS ON THE PATIENT SIDE CART (PSC) COLLIDED AND AN UNSPECIFIED SYSTEM ERROR WAS GENERATED. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER ALLEGED THAT AN UNSPECIFIED INSTRUMENT ADVANCED ABRUPTLY AND HIT THE MUCOSA OF THE BOWEL. THE SURGEON APPLIED A COUPLE OF STITCHES TO ADDRESS THE BOWEL MUCOSA. IT WAS ALSO REPORTED THAT AN INSTRUMENT GOT STUCK ON ONE OF THE ROBOTIC ARMS. ON 10/04/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR (THE INITIAL REPORTER), AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ROBOTICS COORDINATOR INDICATED THAT THE ROBOTIC ARM COLLIDED BEFORE A CADIERE FORCEPS INSTRUMENT GOT STUCK ON ONE OF THE ROBOTIC ARMS. THE ROBOTICS COORDINATOR CLARIFIED THAT THE CADIERE FORCEPS INSTRUMENT ADVANCED ABRUPTLY DURING ATTEMPTS BY THE SURGICAL STAFF TO REMOVE THE STUCK INSTRUMENT. AS A RESULT, THE PATIENT REPORTEDLY SUSTAINED A SLIGHT NICK ON THE BOWEL MUCOSA. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS AND WAS DISCHARGED HOME AT THE EXPECTED TIME. THE CADIERE FORCEPS INSTRUMENT WAS DISCARDED BY THE SITE. THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ROBOTIC ARM OR INSTRUMENT ISSUES AT THE SITE. ON 10/10/2017, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUES. THE FSE INSPECTED AND TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE." } ], "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": "" } ] }