{ "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": "2955842-2014-03638", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140613", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140516", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140613", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "349476", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140613", "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 A60.8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Improper or Incorrect Procedure or Method", "Misfire" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20140613", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20140516", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3872469", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140516", "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": "11975444", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT PATIENT'S INTRA-OPERATIVE COMPLICATION WAS CAUSED BY USER-ERROR. THE SURGEON HAD PRESSED THE CAUTERY PEDAL ON THE SSC WHILE A COVIDIEN ELECTRO-CAUTERY PENCIL INSTRUMENT WAS PLUGGED INTO THE MONOPOLAR RECEPTACLE ON THE ESU AND WAS LYING ON THE PATIENT'S STOMACH. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED AN UNSPECIFIED EXTERNAL BURN WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USER-ERROR." }, { "mdr_text_key": "4457780", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE ELECTROSURGICAL UNIT (ESU) MISFIRED AND THE PATIENT SUSTAINED AN EXTERNAL BURN. SPECIFIC DETAILS REGARDING THE BURN WERE NOT PROVIDED. ON THE SAME DAY THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE TESTED THE SYSTEM USING THE ORIGINAL MONOPOLAR CABLE AND GROUNDING PAD USED DURING THE REPORTED EVENT. NO ISSUES WERE FOUND WITH THE ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THE FSE WAS ABLE TO SIMULATE CAUTERY ON THE DA VINCI SURGICAL SYSTEM USING A SPONGE SOAKED IN SALT WATER. THE FSE ALSO VERIFIED THAT WITH THE DA VINCI INSTRUMENT REMOVED OR WITH THE HEAD SENSOR BLOCKED, THE SSC WOULD NOT ACTIVATE THE ESU. THE FSE REVIEWED SITE'S SYSTEM ERROR LOGS. NO ERRORS RELATED TO THE SSC AND PERSONALITY MODULE ENERGY DEVICE (PMED) WHERE THE ESU IS PLUGGED INTO WERE FOUND. THE FSE THEN TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(4) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SITE DISCOVERED THAT DURING THE SURGICAL PROCEDURE, THE SURGICAL STAFF HAD PLACED A COVIDIEN ELECTRO-CAUTERY PENCIL INSTRUMENT ON THE PATIENT'S STOMACH. WHEN THE EVENT OCCURRED, THE SURGEON PRESSED THE CAUTERY FOOT PEDAL ON THE SSC TO USE A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. AT THAT TIME, HE DID NOT KNOW THAT THE COVIDIEN ELECTRO-CAUTERY PENCIL INSTRUMENT WAS PLUGGED INTO THE MONOPOLAR RECEPTACLE OF THE ESU INSTEAD OF THE MCS INSTRUMENT. WHEN THE CAUTERY PEDAL WAS PRESSED, THE COVIDIEN ELECTRO-CAUTERY PENCIL FIRED, CAUSING THE PATIENT TO SUSTAIN A BURN ON HER STOMACH. THE INJURY TO THE PATIENT'S STOMACH WAS REPAIRED WITH EXCISION(S) AND SUTURES." }, { "mdr_text_key": "30525063", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INITIAL MDR WAS INCORRECTLY CODED WITH AN EVALUATION CONCLUSION CODE OF (B)(4)." } ], "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": "06/13/2014" } ] }