{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-12558", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220629", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220629", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2379071", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220629", "brand_name": "DA VINCI", "generic_name": "DA VINCI XI SURGICAL SYSTEM", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "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": "R", "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": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220629", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20200925", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14860043", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200925", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "295058202", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED VIA A SOCIAL MEDIA POST THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT PEDAL AND BURNED THE COLON. THE SURGEON RECOGNIZED THE ERROR AND WAS ABLE TO STAPLE MORE PROXIMALLY. ON 29-SEP-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING AN UNDISCLOSED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC) AND THE PATIENT SUSTAINED A SMALL 2ND DEGREE BURN ON THE SMALL INTESTINE; REPAIRED BY RESECTING 2CM OF THE SMALL INTESTINE. THE PATIENT WAS REPORTED AS FINE. THE SURGEON CONFIRMED THAT THERE [WASN¿T A] DA VINCI ERROR. THE SURGEON ATTRIBUTED THE ISSUE TO HIS ¿MALFUNCTION¿; SURGEON ERROR, NOTHING ELSE. THE SURGEON WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT." }, { "mdr_text_key": "295058203", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION IS MOST LIKELY DUE TO USE ERROR AS STATED BY THE SURGEON. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A FIELD SERVICE ENGINEER (FSE) INVESTIGATION AND/OR FAILURE ANALYSIS (FA) INVESTIGATION WAS NOT REQUIRED; NO SYSTEM OR INSTRUMENT DETAIL WAS SUPPLIED. SYSTEM ERROR LOG REVIEW WAS UNABLE TO BE PERFORMED DUE TO LACK OF SYSTEM AND INSTRUMENT INFORMATION. LOGS SHOW TWO XI SYSTEMS AT THIS SITE: SK0414 AND SK3585. UNABLE TO RESEARCH FURTHER AS THE EVENT DATE IS UNKNOWN. A REVIEW OF THE INSTRUMENT LOGS WAS UNABLE TO BE PERFORMED DUE TO LACK OF SYSTEM AND INSTRUMENT INFORMATION. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY THE ISI CLINICAL DEVELOPMENT ENGINEER (CDE) TEAM AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE VIDEO SHOWS A FENESTRATED BIPOLAR FORCEPS INSTRUMENT THAT WAS HOLDING TISSUE WITH THE LEFT HAND AS THE SURGEON USED A VESSEL SEALER IN THE RIGHT HAND TO GRAB AN AREA THAT WAS BLEEDING FOLLOWING A STAPLER FIRE. INSTEAD OF ACTIVATING ENERGY IN THE RIGHT HAND (VESSEL SEALER) TO ADDRESS THE BLEEDING, THE SURGEON ACTIVATED ENERGY IN THE LEFT HAND AND INADVERTENTLY BURNED TISSUE. THE SURGEON RECOGNIZED THE ISSUE IMMEDIATELY AND USED A STAPLER TO STAPLE MORE PROXIMALLY AND REMOVE THE AFFECTED TISSUE. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING AN UNDISCLOSED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC) AND THE PATIENT SUSTAINED A SMALL SECOND DEGREE BURN ON THE SMALL INTESTINE; REPAIRED BY RESECTING TWO CM OF THE SMALL INTESTINE. THE PATIENT WAS REPORTED AS FINE. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS ARE NOT AVAILABLE FIELDS ARE NOT APPLICABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }