{ "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": "Death", "report_number": "2955842-2010-00306", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20100710", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "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": "20100831", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100710", "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": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P4", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Failure to Power Up" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20100710", "sequence_number_treatment": [ "DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES AND ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20100827", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1751478", "removal_correction_number": "", "number_devices_in_event": "", "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": "1584557", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6), 2010 (B)(6), RISK MANAGER AT (B)(6) HOSPITAL, SUBMITTED A LETTER AFTER REVIEWING MEDWATCH MANUFACTURER REPORT NUMBER 2955842-2010-00306 STATING: AT NO TIME DURING THE LAPAROSCOPIC PROCEDURE DID THE DA VINCI SI SURGEON SIDE CONSOLE EXPERIENCE A LOSS OF POWER WHILE IN USE NOR WAS THE AORTA NICKED AS INDICATED IN THE MEDWATCH REPORT. ALTHOUGH A CALL WAS PLACED BY OPERATING ROOM PERSONNEL TO AN INTUITIVE SURGICAL TECHNICAL SUPPORT FIELD ENGINEER ON (B)(6), THIS CALL WAS PLACED AFTER THE PROCEDURE CONCLUDED. IT WAS NOTED DURING A CHECK OF THE EQUIPMENT AFTER THE PROCEDURE THAT THE SURGICAL SIDE CONSOLE WOULD NOT POWER ON. IT IS MY UNDERSTANDING THAT DURING THE TROUBLESHOOTING CONVERSATION BETWEEN THE OPERATING ROOM PERSONNEL AND THE TECHNICAL SUPPORT FIELD ENGINEER THAT IT WAS REPORTED TO THE TECHNICAL SUPPORT FIELD ENGINEER THAT A DEFIBRILLATOR HAD BEEN PLUGGED INTO THE SAME ELECTRICAL WALL SOCKET AS THE SURGICAL SIDE CONSOLE AND THAT THE DEFIBRILLATOR HAD BEEN ACTIVATED. PLEASE BE ADVICED THAT THE DEFIBRILLATOR WAS NOT ACTIVATED DURING THE DA VINCI PROCEDURE." }, { "mdr_text_key": "8694572", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS STATED BY (B)(6) THE INITIAL EVENT REPORTED BY INTUITIVE SURGICAL ON JULY 9, 2010 VIA MEDWATCH MANUFACTURER REPORT NUMBER 2955842-2010-00306, WAS INACCURATE. (B)(6) STATED THAT SHE IS UNABLE TO PROVIDE INTUITIVE SURGICAL ANY ADDITIONAL INFORMATION ABOUT THIS CASE AND IF THE FDA REQUIRES ADDITIONAL INFORMATION THAT INTUITIVE SURGICAL REFER THEM DIRECTLY TO HER." }, { "mdr_text_key": "16090763", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION, INCLUDING THE SURGICAL REPORT AND PATIENT'S AUTOPSY REPORT, HAVE BEEN MADE HOWEVER AT THE TIME OF THIS REPORT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL TO INTUITIVE SURGICAL. THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF JULY 8, 2010, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI SI SURGICAL SYSTEM AND NO SIMILAR INSTANCES OF THIS EVENT HAS BEEN REPORTED TO ISI." }, { "mdr_text_key": "16111199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AN UNKNOWN EVENT OCCURRED REQUIRING THE SITE TO USE A DELIBERATOR ON THE PATIENT. AFTER THIS EVENT, THE SITE WANTED TO CONTINUE WITH THE SCHEDULED PROCEDURE; HOWEVER, THE SYSTEM WOULD NOT POWER BACK ON. A TECHNICAL SUPPORT ENGINEER WAS CALLED TO TROUBLESHOOT THE PROBLEM AND THE POWER BREAKER ON THE SURGEON SIDE CONSOLED (SSC) WAS FOUND TO REQUIRE CYCLING. AT THIS TIME THE SYSTEM IMMEDIATELY POWERED UP AND THE SITE CONFIRMED THAT THE SYSTEM IS WORKING PROPERLY. SHORTLY AFTER THE SURGEON CONSOLE POWERED UP, IT WAS REPORTED THAT THE PATIENT'S AORTA WAS NICKED AND THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES DUE TO PATIENT COMPLICATIONS. IT WAS REPORTED THAT THE PATIENT EXPIRED SHORTLY AFTER THE CONVERSION." } ], "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": "08/31/2010" } ] }