{ "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": "2955842-2015-01049", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20150730", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20090427", "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", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150731", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "497282", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150730", "brand_name": "DA VINCI 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": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20150730", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Pneumonia", "Pneumonia", "Sepsis", "Sepsis", "Discomfort", "Discomfort", "Abdominal Distention", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20150714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4955115", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150714", "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": "16503151", "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 THAT UNDERWENT A DA VINCI ASSISTED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL PERIAORTIC LYMPHADENECTOMY, AND OMENTECTOMY ON (B)(6) 2009 FOR CLINICAL STAGE II UTERINE SEROUS CARCINOMA. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. PER THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED, EXTUBATED, AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 50 ML. ON (B)(6) 2009, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AND ANASTOMOSIS. PER THE OPERATIVE REPORT, THE PATIENT HAD DEVELOPED RIGHT LOWER LOBE PNEUMONIA AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2009 AND WAS NOTED TO BE CLINICALLY SEPTIC WITH INCREASING ABDOMINAL DISTENSION AND DISCOMFORT SUSPICIOUS FOR AN UNDERLYING ABDOMINAL PROCESS DESPITE THE ABSENCE OF EVIDENCE ON ABDOMINAL PELVIC CT SCAN. OPERATIVE FINDINGS INCLUDED THE FOLLOWING: A 5 MM ENTEROTOMY IN THE ILEUM, A SMALL AMOUNT OF SMALL BOWEL SUCCUS PRESENT INTRA-ABDOMINALLY, DISTENDED SMALL BOWEL LOOPS. THE ASCENDING, TRANSVERSE, DESCENDING, AND SIGMOID COLON WERE NOTED TO BE UNREMARKABLE. THE REMAINDER OF THE SMALL BOWEL WAS ALSO NOTED TO BE UNREMARKABLE. NO ABSCESSES OR COLLECTIONS WERE FOUND. THE ESTIMATED BLOOD LOSS FOR THE SURGICAL PROCEDURE WAS MINIMAL. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT PASSED AWAY 19 MONTHS LATER. HOWEVER, NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW TO SUPPORT THE CLAIM OF THE PATIENT'S DEMISE." }, { "mdr_text_key": "16615038", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. THE PLAINTIFF'S ATTORNEY CLAIMED THAT THE PATIENT PASSED AWAY APPROXIMATELY 19 MONTHS POST-OPERATIVELY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "32220180", "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. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED AN INJURY TO HER SMALL BOWEL AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE. THE PLAINTIFF'S ATTORNEY FURTHER ALLEGES THAT THE PATIENT'S DEATH WAS A RESULT OF AN INJURY SUSTAINED WHILE UNDERGOING THE DA VINCI SURGICAL PROCEDURE. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMED THAT THE PATIENT PASSED AWAY AS A RESULT OF AN INTRA-OPERATIVE INJURY SUSTAINED DURING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATION(S) AND SUBSEQUENT DEMISE ARE STILL UNKNOWN." }, { "mdr_text_key": "47399055", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 05/19/2016, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL EXPERT/SURGEON REVIEWED A VIDEO OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT. BASED ON THE REVIEW OF THE VIDEO, THE CLINICAL EXPERT EXPRESSED CONCERN REGARDING THE CONSOLE SURGEON'S OPERATIVE TECHNIQUES AND MANNERS. ACCORDING TO THE CLINICAL EXPERT, THE CONSOLE SURGEON WAS NOT PROPERLY USING AN UNSPECIFIED BOVIE INSTRUMENT NEAR CRITICAL STRUCTURES. THE VIDEO REVEALED THAT THE SURGEON WAS MANIPULATING TISSUE BLINDLY AND WITHOUT DIRECT VISUALIZATION. THE DA VINCI SURGICAL SYSTEM MANUAL STATES, CAUTION: INSTRUMENT TIPS SHOULD BE KEPT IN THE VIEW OF THE SURGEON AT ALL TIMES. THE VIDEO ALSO SHOWED JARRING MOVEMENTS AND THE CAMERA COMING IN AND OUT QUICKLY. AS A RESULT, A CLEAR VIEW OF THE ANATOMY WAS NOT CONTINUOUSLY ACHIEVED. IN ADDITION, THE CLINICAL EXPERT INDICATED THAT THE CONSOLE SURGEON USED A LOT OF CAUTERY IN AREAS NOT RECOMMENDED. THE CLINICAL EXPERT ALSO INDICATED THAT THE CONSOLE SURGEON HAD USED CAUTERY WHILE MANIPULATING THE PATIENT'S BOWEL. WITHIN THE VIDEO PROVIDED, THE CLINICAL EXPERT OBSERVED GREEN MATERIAL/FLUID IN THE SURGICAL FIELD THAT WAS SUCTIONED OUT. THE CLINICAL EXPERT CONCLUDED THAT A BOWEL INJURY HAD LIKELY OCCURRED DURING THE SURGICAL PROCEDURE AND WAS PRESENT WHEN THE SURGEON CLOSED THE PATIENT. AS NOTED IN THE INITIAL MDR SUBMISSION, A REVIEW OF THE OPERATIVE REPORT REVEALED THAT NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY PROCEDURE, THE PATIENT REPORTEDLY SUSTAINED AN INTRA-OPERATIVE BOWEL INJURY AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH ARE UNKNOWN." } ], "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": "06/10/2016" } ] }