{ "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": "2955842-2014-01380", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140307", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20130325", "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": "20140307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "140630", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140307", "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", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20140307", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Hypovolemic Shock", "Myocardial Infarction", "Seizures" ] } ], "distributor_city": "", "date_report": "20140208", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3667313", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140208", "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": "11637542", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE OF THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ISI HAS CONTACTED THE RISK MANAGEMENT GROUP AT THE SITE TO GATHER ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT." }, { "mdr_text_key": "4202065", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO EXPIRED AFTER UNDERGOING A TONSILLECTOMY, PHARYNGECTOMY, PARTIAL GLOSSECTOMY USING THE DA VINCI SURGICAL SYSTEM FOR TONSILLAR CANCER ON (B)(6) 2013. REPORTEDLY, THE SURGERY WAS PART OF A RESEARCH STUDY CLEARED BY THE FDA. THE PATIENT'S MEDICAL RECORDS WERE PROVIDED TO ISI FOR REVIEW. ACCORDING TO THE INFORMATION IN THE PATIENT'S OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S SUBSEQUENT POST SURGICAL COMPLICATIONS AND DEATH. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS EXTUBATED WITHOUT INCIDENT IN THE OPERATING ROOM AND WAS TRANSFERRED IN STABLE CONDITION TO THE RECOVERY ROOM. NO COMPLICATIONS WERE EXPERIENCED BY THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. BASED ON THE INFORMATION PROVIDED IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM DUE TO SIGNIFICANT ORAL BLEEDING AND PEA ARREST WITH ROSC AFTER APPROXIMATELY 12 MINUTES OF CPR, DURING WHICH HE WAS ADMINISTERED 2 ROUNDS OF ATROPINE AND 3 ROUNDS OF EPINEPHRINE. THE PATIENT WAS TAKEN INTO THE OPERATING ROOM WHERE IT WAS DISCOVERED THAT THE PATIENT HAD TWO ARTERIAL SITES OF BLEEDING. THE AFFECTED AREAS WERE CLIPPED WITH SUBSEQUENT HEMOSTATIS. REPORTEDLY, THE PATIENT LOST 1.5 LITERS OF BLOOD AND WAS GIVEN 5 UNITS OF PACKED RED BLOOD CELLS. AFTER THE SURGICAL PROCEDURE, THE PATIENT DEVELOPED SEIZURE-LIKE JERKING MOVEMENTS AND WAS EVALUATED BY NEUROLOGY AND WAS GIVEN 1 G OF DILANTIN PRIOR TO TRANSFER. A PRELIMINARY CT SCAN READING SHOWED THAT THE PATIENT HAD NO ACUTE INTRACRANIAL ABNORMALITY, EDEMA, BLEEDING, BUT DID SHOW CHRONIC WHITE MATTER DISEASE. A CEEG SHOWED THAT THE PATIENT HAD EPILEPTICUS. IT WAS STATED IN THE PATIENT'S HOSPITAL ENCOUNTER NOTES THAT ON (B)(6) 2013, THE PATIENT'S FAMILY MADE THE DECISION TO MAKE THE PATIENT DNR INITIALLY AND LATER THE DECISION WAS MADE TO PURSUE COMFORT CARE MEASURES. THE PATIENT WAS EXTUBATED, PER PROTOCOL, AND EXPIRED SOON THEREAFTER. ACCORDING TO THE HOSPITAL ENCOUNTER NOTES, THE LIKELY CAUSE OF THE PATIENT'S DEMISE WAS SEVERE HEMORRHAGIC SHOCK LEADING TO A MYOCARDIAL INFARCTION DUE TO HYPOVOLEMIC SHOCK." } ], "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": "" } ] }