{ "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": "2955842-2020-10608", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200630", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "LITERATURE", "STUDY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "677610", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200630", "brand_name": "DA VINCI SYSTEM", "generic_name": "DA VINCI", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "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": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20200630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20190421", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10212419", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190421", "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": "201185329", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FOLLOWING INFORMATION IS UNKNOWN: TYPE OF SURGICAL PROCEDURE PERFORMED, DATE THE SURGICAL PROCEDURE WAS PERFORMED, WHAT SITE AT WHICH THE PROCEDURE WAS PERFORMED, THE NAME OF THE SURGEON WHO PERFORMED THE SURGERY, WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE RECTAL INJURY OCCURRED, WHAT SYSTEM WAS USED, WHAT INSTRUMENTATION OR OTHER PRODUCTS WERE INVOLVED IN THE COLLISION, AND WHAT THE PATIENT¿S CURRENT STATUS IS. NO FURTHER INVESTIGATION COULD BE PERFORMED AS THE DATE, SYSTEM, SURGEON, AND SITE WERE UNKNOWN. IN ADDITION, NO PRODUCT WILL BE RETURNED FOR ANALYSIS. THIS COMPLAINT IS BEING REPORTED BECAUSE A RECTAL INJURY OF AN UNKNOWN SEVERITY OCCURRED AND THERE IS INSUFFICIENT INFORMATION TO CONCLUDE THAT AN ISI PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INJURY. THE PATIENT INFORMATION IS UNKNOWABLE AT THIS TIME AS THE INFORMATION WAS NOT PROVIDED BY THE AUTHORS OF THE LITERATURE AND NO SITE OR FURTHER CONTACT INFORMATION WAS PROVIDED. THE EXPIRATION DATE IS NOT APPLICABLE. THIS REPORT HAS BEEN GENERATED IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED 06-MAR-2020." }, { "mdr_text_key": "201185330", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN REGARD TO THE ARTICLE ¿EARLY FEASIBILITY SURVEILLANCE OF GYNECOLOGIC ROBOTIC-ASSISTED SURGERIES IN JAPAN¿ WRITTEN BY TSUKASA BABA, MASAKI MANDAI, HIROTAKA NISHI, OSAMU NISHII, JO KITAWAKI, MORIO SAWADA, KEIICHI ISAKA AND TOMOYUKI FUJII, AND PUBLISHED IN THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH, DR. TSUKASA BABA INDICATED THAT HE HEARD OF A COLLISION INDUCED RECTAL INJURY THAT OCCURRED ¿OUTSIDE OF VIEW.¿ DR. BABA INDICATED THAT HE WAS ¿NOT SURE [IF] THE PATIENT SUFFERED FROM SEPTIC SHOCK OR UNDERWENT ANASTOMOSE OR OTHER INTENSIVE CARE.¿ INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT, BUT AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED." } ], "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": "" } ] }