{ "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": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5076019", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20180322", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20170724", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "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": "20180323", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "204062", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180322", "brand_name": "DA VINCI ROBOT", "generic_name": "DA VINCI ROBOT", "manufacturer_d_name": "INTUITIVE SURGICAL, INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "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": [ "Patient-Device Incompatibility" ], "reporter_state_code": "MN", "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": "20180322", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " O", " R", " S" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "57", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Burn, Thermal", "Injury", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20180321", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7365655", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary 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": "103443538", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DAVINCI ROBOT CUT MY JEJUNUM THROUGH AND THROUGH BURNED MY SIGMOID COLON DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) CLINIC PERFORMED BY DR (B)(6). THERE WERE NO TROCARS INSERTED WHERE THERE WERE INJURIES. I BELIEVE THE FDA ERRED IN ALLOWING THIS DEVICE TO CONTINUE TO BE USED IN THE MEDICAL. I BELIEVE IT IS NOT SAFE AND THE PART ISSUES HAVE NOT BEEN REMEDIED. I BELIEVE THE FDA DID NOT AND DOES NOT CONTINUE TO MONITOR AND REGULATE INTUITIVE SURGICAL AS THERE CONTINUES TO BE INJURIES AND DEATHS SURROUNDING THE DAVINCI ROBOT. I ALSO BELIEVE THERE ARE VIOLATIONS AROUND ADVERSE EVENT REPORTING BASED ON THE FACT MY INJURIES WERE NOT REPORTED AS WELL AS A NUMBER OF INDIVIDUALS I HAVE TALKED TO WHO HAVE ALSO SUFFERED INJURIES FROM THE DAVINCI ROBOT. PER PREVIOUS COMMITMENTS FROM INTUITIVE SURGICAL TO FDA, PLEASE ADVISE ON THE FOLLOWING: INTUITIVE USES A (B)(4) AVIATION MFR TO MAKE SOME OF THEIR COMPONENTS IN THE DAVINCI ROBOT NAMED EASTON. DO THEY STILL CONTINUE TO USE THIS 3RD PARTY AND WHY THEY NEVER TESTED THE MATERIAL IN THE TUBES. ALSO, WHAT TYPE OF MATERIALS ARE USED AND HOW IS THIS MONITORED AND REGULATED. HISTORICALLY, INTUITIVE KNEW THE COMPOSITE MATERIAL WAS NOT SUITED FOR HIGH TEMPS AND ELECTRICITY. (REF THE MULLENEX DECLARATION). INTUITIVE HISTORICALLY STATED THEY KNEW OF THE ISSUE SINCE 2007. AND THEN LIED TO THE FDA ABOUT INJURIES, THEN OPTED TO TELL THE TRUTH ABOUT INJURIES. HOW/WHAT IS DONE TO MAKE SURE THIS DOESN'T REOCCUR. HOW WILL ANYONE KNOW THAT THE ISSUE HASN'T RESURFACED IF WE AREN'T SAVING THE TIP COVERS ETC, AND ISI HAS NO INTEREST IN POST INCIDENT REVIEWS. MY RESPONSE FROM INTUITIVE WAS \"IT WASN'T US IT WAS THE SURGEON TALK TO THEM.\" ISI NEVER ASKED FOR ANY SPECIFIC. NOT IN THE SPIRIT OF A SILICON VALLEY COMPANY. THERE WAS NO INTEREST IN MAKING THEMSELVES A BETTER COMPANY OR SEE UNDERSTANDING WHAT REALLY HAPPENED. NO REQUESTS FOR EVENT LOGS OR PRODUCT SPECS. HOW IS THIS HANDLED FROM COMPLIANCE. HOW DO WE FIND OUT THE GRANULAR MFR PROCESS AND COMPONENTS USED IN THE SCISSORS TIPS ETC TO MAKE SURE THE OLD PROBLEMS HAVEN'T BEEN REINTRODUCED. HOW DO WE FIND OUT ABOUT THE ROBOTIC ID AND SERIAL NUMBERS OF PARTS. HOW DO WE KNOW THE PARTS BEING USED ARE THE REMEDIATED ONES. PLANS ON STORING DISPOSABLE COMPONENTS FOR FUTURE FAILURE ANALYSIS. CURRENT REGULATIONS FOR HOSPITALS CRITERIA FOR CERTIFICATION AND TRAINING FOR DRS FOR USING THE ROBOT. HOW DO WE FIND OUT ABOUT PRODUCT WARNINGS FROM ISI TO HOSPITALS AND /OR DRS, AND WHO DECIDES WHAT IS APPROPRIATE FOR WARNINGS. MAYO CLINIC WILL NOT PROVIDE ANY." } ], "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": "" } ] }