{ "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": "2955842-2014-00247", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140114", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131210", "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": "20140114", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "37406", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140114", "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": "", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "NM", "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": "20140114", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Tissue Damage", "Injury", "Malaise" ] } ], "distributor_city": "", "date_report": "20131215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3574589", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131215", "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": "15633578", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A TRANSVERSE COLON INJURY WAS FOUND WITH A PATIENT WHO UNDERWENT A DA VINCI CHOLECYSTECTOMY PROCEDURE. TWO DAYS POST DA VINCI SURGICAL PROCEDURE, THE PATIENT UNDERWENT AN OPEN EXPLORATORY SURGICAL PROCEDURE TO REPAIR THE INJURY. THE CAUSE OF THE INJURY IS UNKNOWN AT THIS TIME AND THERE WAS NO ALLEGATION OF A MALFUNCTION WITH THE DA VINCI SYSTEM AND/OR INSTRUMENTS AND ACCESSORIES." }, { "mdr_text_key": "15175150", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE REPORTED A TRANSVERSE COLON INJURY THAT WAS OBSERVED AFTER A PATIENT WHO UNDERWENT A DA VINCI CHOLECYSTECTOMY SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGERY ON AN UNKNOWN DATE. NO OTHER DETAILS WERE PROVIDED AT THE TIME. ON (B)(4) 2014, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER: THE PATIENT WAS A MALE WHO WAS (B)(6) (WEIGHT=UNKNOWN). THE INITIAL REPORTER SPOKE WITH THE SITE AND WAS NOT INFORMED OF ANY INTRA-SURGICAL COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM AND/OR INSTRUMENT/ACCESSORIES. ON AN UNSPECIFIED DATE FOLLOWING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT STARTED TO FEEL SICK. TWO DAYS POST DA VINCI SURGERY ((B)(6) 2013), THE SAME DA VINCI SURGEON PERFORMED AN OPEN EXPLORATORY SURGERY AND FOUND THE PATIENT'S TRANSVERSE COLON WAS CUT. THE INJURY WAS REPAIRED AND THE PATIENT WAS HOSPITALIZED FOR A COUPLE WEEKS. PATIENT WAS DISCHARGED AROUND (B)(6) 2014 TO A REHAB FACILITY FOR AN UNDETERMINED TIME PERIOD. THE SURGEON DOES NOT KNOW WHEN THE INJURY OCCURRED AND HOW IT HAPPENED BUT BELIEVES THE INJURY MAY BE RELATED TO USE ERROR (INSTRUMENT INSERTION) OR DUE TO THE PATIENT'S ANATOMY (ADHESIONS). THE SURGEON DECLINED TO PROVIDE ANYMORE INFORMATION TO THE ISI REPRESENTATIVE." } ], "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": "" } ] }