{ "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": "2955842-2011-00116", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20110421", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110318", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110421", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110421", "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 A6.0P5", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20110421", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stroke/CVA", "Death", "Embolus", "Neurological Deficit/Dysfunction", "Paralysis", "Vascular System (Circulation), Impaired" ] } ], "distributor_city": "", "date_report": "20110325", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2065919", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150213", "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": "17960404", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO MALFUNCTIONS OF THE DA VINCI SI SURGICAL SYSTEM WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE AND THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF (B)(4), 2011, NO SIMILAR INSTANCES HAVE BEEN REPORTED TO (B)(4)." }, { "mdr_text_key": "12888403", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2011 FOR UTERINE LEIOMYOMATA AND ABNORMAL VAGINAL BLEEDING. ISI WAS PROVIDED WITH THE PATIENT'S AUTOPSY REPORT. PER THE AUTOPSY REPORT, THE AUTOPSY WAS PERFORMED ON (B)(6) 2011. THE CAUSE OF DEATH WAS NOTED AS, COMPLICATIONS OF CEREBRAL INFARCTS WITH THROMBO-EMBOLIC OCCLUSION OF RIGHT INTERNAL CAROTID ARTERY FOLLOWING ELECTIVE HYSTERECTOMY FOR TREATMENT OF UTERINE LEIOMYOMATA. THE MANNER OF DEATH WAS NOTED AS THERAPEUTIC COMPLICATION. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMED THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "12936930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, THE PATIENT UNDERWENT A DA VINCI-ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND LYSIS OF ADHESIONS ON (B)(6) 2011 FOR FIBROID UTERUS AND MENORRHAGIA. ACCORDING TO THE OPERATIVE REPORT, ABDOMINAL AND FUNDAL ADHESIONS WERE LYSED USING PK GRASPERS AND MONOPOLAR SCISSORS, AND THE UTERUS WAS REMOVED VIA MORCELLATION. NO OPERATIVE COMPLICATIONS WERE NOTED, AND THE ESTIMATED BLOOD LOSS WAS 250 ML. UPON WAKING UP POST-OPERATIVELY, THE PATIENT WAS FOUND TO HAVE RIGHT SIDED HEMIPLEGIA AND LEFT GAZE DEVIATION. SERIAL CT-SCANS SHOWED INCREASING SHIFT FROM ACA [ANTERIOR CEREBRAL ARTERY] AND MCA [MIDDLE CEREBRAL ARTERY] CVA [CEREBROVASCULAR ACCIDENT]. THE PATIENT UNDERWENT A LEFT HEMICRANIECTOMY ON (B)(6) 2011 WITH A TWO MD CONSENT FOR IMPENDING HERNIATION, AS THE ONLY FAMILY AVAILABLE WAS A MINOR CHILD. A CT ANGIOGRAM OF THE NECK ON (B)(6) 2011 REVEALED FOCAL THROMBUS WITHIN THE AORTIC ARCH AND COMPLETE OCCLUSION OF THE LEFT CERVICAL INTERNAL CAROTID ARTERY, WITH NO EVIDENCE OF CAROTID ARTERY DISSECTION. ON (B)(6) 2011, THE PATIENT UNDERWENT GASTROSTOMY TUBE PLACEMENT. HE WAS HOSPITALIZED (B)(6)2011 -(B)(6) 2011 [DISCHARGE SUMMARY WAS NOT PROVIDED], AND TRANSFERRED TO A REHABILITATION CENTER ON (B)(6) 2011. AT REHAB, THE PATIENT WAS REPORTEDLY ABLE TO SIT IN A CHAIR AND WAS ALERT AND RECOGNIZED FAMILY MEMBERS; HOWEVER, SHE REMAINED NON-VERBAL AND WAS NOT WALKING [RECORDS FROM THE REHABILITATION CENTER WERE NOT PROVIDED]. ON (B)(6) 2011, THE PATIENT WAS FOUND UNRESPONSIVE AND TRANSFERRED BACK TO THE HOSPITAL. A CT-SCAN OF THE HEAD REVEALED SMALL FRONTAL HEMORRHAGIC CONVERSION, AND AN MRI/MRA ON (B)(6) 2011 SHOWED A NEW RIGHT SIDED CEREBRAL INFARCT. THE PATIENT ALSO EXPERIENCED DIABETES INSIPIDUS WITH AN INABILITY TO BE WEANED OFF OF A VENT. A DNR ORDER WITHOUT CAPACITY AND WITH A SURROGATE [THE PATIENT'S BROTHER] EXECUTED ON (B)(6) 2011. THE PATIENT'S BROTHER FELT THAT THE PATIENT WAS PERMANENTLY UNCONSCIOUS. THE PATIENT SUDDENLY BECAME UNRESPONSIVE ON (B)(6) 2011 AND WAS PRONOUNCED DEAD AT 12:09 PM [THE DISCHARGE SUMMARY WAS NOT PROVIDED]. AN AUTOPSY WAS CONDUCTED ON (B)(6) 2011. THE CAUSE OF DEATH WAS NOTED AS COMPLICATIONS OF CEREBRAL INFARCTS WITH THROMBOEMBOLIC OCCLUSION OF RIGHT INTERNAL CAROTID ARTERY FOLLOWING ELECTIVE HYSTERECTOMY FOR TREATMENT OF UTERINE LEIOMYOMATA. THE MANNER OF DEATH WAS NOTED AS THERAPEUTIC COMPLICATION. TOXICOLOGY WAS ESSENTIALLY NORMAL, WITH ONLY LIDOCAINE DETECTED. MOLECULAR GENETIC TESTING SHOWED THAT NO MUTATIONS WERE DETECTED FOR FACTOR V LEIDEN, PROTHROMBIN, OR MTHFR. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT IS BEING RETRACTED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. IN ADDITION, THERE IS NO INDICATION THAT THE THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE. THE PATIENT SUFFERED A CATASTROPHIC STROKE PERIOPERATIVELY. A STROKE IS AN INFREQUENT COMPLICATION WHICH OCCURS IN 0.03% OF GYNECOLOGICAL SURGERY AND IS NOT DIRECTLY RATED TO THE OPERATION OR TYPE OF OPERATIVE APPROACH. THIS COMPLICATION IS PRIMARILY CAUSED BY PREEXISTING MEDICAL CONDITIONS AND RISK FACTORS AND IN NO WAY IN THIS CASE COULD BE ASCRIBED TO THE DA VINCI SURGERY." }, { "mdr_text_key": "18043779", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT SUFFERED A PERIOPERATIVE LEFT HEMISPHERE CEREBROVASCULAR ACCIDENT (CVA) SECONDARY TO COMPLETE OCCLUSION OF LEFT CAROTID ARTERY (EMBOLIC). POSTOPERATIVELY NOTED TO BE COMPLETELY APHAGIC AND RIGHT HEMIPLEGIC. A CLOT WAS IDENTIFIED VIA MRA IMAGING FROM BIFURCATION OF AORTA. NO H/O HYPERCOAGULABILITY. FIBROMUSCULAR HYPERPLASIA (FMH) SIGNIFICANT FOR MOTHER SUFFERING FATAL CEREBROVASCULAR ACCIDENT (CVA). REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM." } ], "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": "02/13/2015;03/02/2015" } ] }