{ "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": "2955842-2012-00960", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20121116", "manufacturer_address_2": "", "pma_pmn_number": "K0801137", "date_of_event": "20121023", "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": "20121119", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121116", "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.P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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 Displays Incorrect Message" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20121116", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20121017", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2836473", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121017", "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": "20598368", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION PERFORMED BY THE ISI FIELD SERVICE ENGINEER WAS ABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE DETERMINED THAT THE UNCOMMANDED CAUTERY ACTIVATION EXPERIENCED BY THE SITE WAS CAUSED BY THE SITE'S VALLEY LAB FORCE 2 ELECTRICAL SURGICAL UNIT (ESU), WHICH IS NOT RECOMMEND FOR USE WITH THE DA VINCI SI SURGICAL SYSTEM. THE FSE TESTED THE SITE'S ESU USING HIS DA VINCI TRUCK STOCK VALLEY LAB ESU CABLE, MONOPOLOR CURVED SCISSORS INSTRUMENT AND A BIPOLAR FORCEPS INSTRUMENT. THE FSE POWERED ON THE ESU WITH THE SETTINGS ESTABLISHED AT 30 FOR BIPOLAR, 30 FOR MONOPOLAR CUT, AND 30 FOR MONOPOLAR COAG, WITH A PURE CUT SETTING (THE ORIGINAL CUT SETTING IS UNKNOWN). THE FSE CONNECTED THE ESU CABLES ON BOTH ENDS FROM THE INSTRUMENT. AFTER APPROXIMATELY 15 MINUTES OF TESTING, AN AUDIBLE BEEP WAS NOTED COMING FROM THE ESU AND THE RETURN ELECTRODE MONITOR (REM) LIGHT ON THE ESU LIT UP. THE FSE THEN CONNECTED THE ESU TO THE SITE'S DA VINCI SURGICAL SYSTEM AND CONNECTED THE ESU CABLE TO THE BACK OF THE ESU AND PRESSED THE MONOPOLAR FOOT PEDALS ON THE SURGEON SIDE CART. AFTER ACTIVATING THE FOOT PEDALS, MONOPOLAR COAG AND CUT BOTH FIRED WHEN PRESSED AND STOPPED FIRING WHEN RELEASED. THE FSE NOTED THAT AN AUDIBLE TONE WAS PRESENT WITH EACH ACTIVATION FROM THE ESU. THE FSE FOUND THAT FOOT PEDAL RECOGNITION SHOWED ACTIVE FOR BOTH MONOPOLAR COAG AND MONOPOLAR CUT WHEN PRESSED AND THERE WAS NO INDICATION OF ACTIVE ENERGY WHEN RELEASED. THE FSE WAS ALSO ABLE TO DUPLICATE THESE RESULTS WITH THE BIPOLAR ENERGY. WHILE ON SITE THE FSE CONSULTED WITH (B)(6) IN THE BIOMEDICAL DEPARTMENT AT (B)(6). THEY INDICATED TO THE FSE THAT THE REM INDICATOR ON THE ESU SHOULD NOT BEEP WITHOUT FOOT PEDAL ACTIVATION AND THAT THE REM LIGHT CAN COME ON WITHOUT CONCERN; HOWEVER, IF AN AUDIBLE NOISE IS PRESENT WITHOUT ACTIVATION AND NOT CONNECTED TO THE SURGEON SIDE CART IT IS ASSOCIATED WITH A FAULT TO THE ESU. THE FSE ADVISED THE SITE THAT THE VALLEY LAB FORCE 2 ELECTRICAL SURGICAL UNIT IS NOT RECOMMENDED FOR USE WITH THE DA VINCI SI SURGICAL SYSTEM AND THE FSE PROVIDED THE SITE WITH A LIST OF THE APPROVED ESUS FOR THE DA VINCI SI SURGICAL SYSTEM. THE FSE INDICATED THAT THE SITE REPORTED THAT THEIR INVESTIGATION INTO THE REPORTED EVENT FOUND NO ISSUE WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT OR THE MARYLAND BIPOLAR INSTRUMENT AND THAT THEY HAVE CONTINUED TO USE THE INSTRUMENTS. IN ADDITION, THE FSE ADVISED THAT THE SITE HAS SEQUESTERED THE VALLEY LAB FORCE 2 ESU AND IS NOW USING AN APPROVED ESU WITH THEIR DA VINCI SI SURGICAL SYSTEM. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: CAUTION: FOR THE VALLEYLAB FORCE 2 (APPROVED FOR USE WITH DA VINCI AND DA VINCI S SYSTEMS ONLY), ERBE ICC 350 AND ERBE VIO 300D, FOLLOW THE SPECIFIC CONFIGURATION INSTRUCTIONS PROVIDED IN THIS SECTION, TO ENSURE THAT THE DESIRED ENERGY IS BEING ACTIVATED FROM THE DA VINCI SURGEON CONSOLE ON (B)(4) 2012, ISI CONTACTED (B)(6) AND SHE INDICATED THAT THE FUNDUS OF THE PATIENT'S UTERUS WAS BURNED; HOWEVER, THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AND REPAIR OF THE AFFECTED AREA WAS NOT REQUIRED, SINCE THE PATIENT'S UTERUS WAS BEING REMOVED AS PART OF THE PLANNED SURGICAL PROCEDURE. (B)(6) INDICATED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO ADVERSE OUTCOME OCCURRED. (B)(6) ALSO INDICATED THAT THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." }, { "mdr_text_key": "11593236", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CORRECTION: EVENT DATE SHOULD BE (B)(6) 2012. DATE RECEIVED BY MANUFACTURE SHOULD BE (B)(4) 2012." }, { "mdr_text_key": "20355102", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHEN THE SCRUB NURSE INSERTED THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND BIPOLAR INSTRUMENT INTO THE PATIENT, AN AUDIBLE SOUND FROM THE ELECTRICAL SURGICAL UNIT (ESU) OCCURRED AND, THE ESU ACTIVATED WHEN THE CIRCULATING NURSE CONNECTED THE BIPOLAR AND MONOPOLAR CABLES TO THE ESU, CAUSING A BURN TO THE FUNDUS OF THE PATIENT'S UTERUS. THE INSTRUMENTS WERE REMOVED AND THEN RE-INSERTED INTO THE PATIENT AND THE SURGEON PROCEEDED WITH THE PROCEDURE. THE SURGICAL STAFF DID NOT EXPERIENCE ANY OTHER ISSUES WITH UNCOMMANDED CAUTERY ACTIVATION AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE OUTCOME." } ], "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": "03/20/2014" } ] }