{ "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": "2955842-2013-00666", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130228", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130129", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "86914", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130228", "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 A60P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130228", "sequence_number_treatment": [ "DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20130129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2983512", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130129", "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": "17925052", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER OF A SUCCESSFUL DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE CANNULA FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED BURN MARKS ON THE SURFACE OF THE SKIN ASSOCIATED WITH PATIENT SIDE MANIPULATOR (PSM) ARM 2." }, { "mdr_text_key": "18050291", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL CONTACTED DAVINCI ROBOTIC COORDINATOR, SHE INDICATED THAT THE PATIENT CONDITION WAS STABLE; THE PATIENT DIDN'T SUFFER ANY FURTHER COMPLICATIONS. ACCORDING TO THE INFORMATION PROVIDED BY HER, THE GROUND PADS WERE CORRECTLY POSITIONED ON THE PATIENT. THE DA VINCI ROBOTIC COORDINATOR ALSO INDICATED THAT A SIMILAR EVENT OCCURRED ON (B)(6) 2013, BUT ISI WAS NOT NOTIFIED AT THE TIME OF THE EVENT. MDR 2955842-2013-00665 WAS CREATED TO ADDRESS THAT EVENT. THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) COULD NOT FIND ANY DAVINCI SYSTEMS MALFUNCTIONS. FSE PERFORMED AN ELECTRICAL SAFETY TEST AND SYSTEM VERIFICATION TEST. FSE VERIFIED THAT ELECTRICAL SAFETY PASSED ON THE VISION SITE CART, SURGEON CONSOLE CART, AND PATIENT SITE CART. HE ALSO VERIFIED THAT ALL 3 OF THE CANNULA MOUNTS WERE ELECTRICALLY ISOLATED FROM THE SYSTEM THROUGH THE RESISTANCE CHECKS. THE DAVINCI ROBOTIC COORDINATOR ALSO INDICATED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 2 AND THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 1. ALL ENERGY LEVELS ON THE ELECTRO SURGICAL UNIT (ESU) WERE CONFIRMED TO BE SET AT 45 AND THE PROCEDURE WAS SIDE DOCKED. THE FOLLOWING MORNING, THE STAFF HAD THE VALLEYLAB GENERATOR (FORCE TRIAD) REPLACED AND TESTED. BIOMED REPORTED THAT VALLEYLAB GENERATOR PASSED ELECTRICAL SAFETY TESTS AND POWER TEST. THE MARYLAND BIPOLAR FORCEPS AND THE MONOPOLAR CURVED SCISSORS INSTRUMENTS WERE RETURNED AND EVALUATED BY ISI; BOTH INSTRUMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENTS TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARMS TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED. HOWEVER, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DEFINITIVELY DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS ISSUE AT THIS HOSPITAL." } ], "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": "" } ] }