{ "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": "2955842-2015-00753", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150515", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150408", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150515", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "318992", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150515", "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 A6.0P8", "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": "TX", "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": "20150515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Injury" ] } ], "distributor_city": "", "date_report": "20150416", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4775657", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150416", "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": "5782887", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT CAME BACK TO THE HOSPITAL AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS. A PHYSICIAN'S ASSISTANT (PA) FROM THE SITE INDICATED THAT AN AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A BOWEL INJURY. THE PA INDICATED THAT THE BOWEL INJURY MIGHT HAVE OCCURRED DURING INITIAL PORT PLACEMENT OF THE DA VINCI SURGICAL PROCEDURE. THE PA ALSO INDICATED THAT IT WAS THE FIRST TIME THAT THE FELLOW HAD INSERTED A TROCAR. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HE INDICATED THAT THE SITE UTILIZES AN ETHICON TROCAR DURING CAMERA PORT PLACEMENT AND AN AIRSEAL TROCAR FOR THE ASSIST PORT PLACEMENT. IN ADDITION, THE SITE UTILIZES ISI TROCARS FOR PLACEMENT OF THE PORT FOR THE ROBOTIC INSTRUMENTS AND ARMS. HE DID NOT KNOW WHICH TROCAR MIGHT HAVE POSSIBLY CAUSED THE BOWEL INJURY. ON (B)(6) 2015, ISI ALSO CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT DURING A PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CTA, THE PA WAS PRESENT DURING THE SURGICAL PROCEDURE AND THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. THE CTA INDICATED THAT THE SITE SUSPECTS THAT THE BOWEL INJURY MIGHT HAVE OCCURRED DURING CUTDOWN OR PORT PLACEMENT BY A FELLOW AT THE BEGINNING OF THE SURGICAL PROCEDURE. THE CTA STATED THAT THE SURGICAL STAFF DID NOT USE DIRECT VISUALIZATION DURING ALL OF THE PORT PLACEMENTS. HE DID NOT KNOW WHAT TYPE OF BOWEL INJURY WAS IDENTIFIED. HE ALSO COULD NOT CONFIRM THE CAUSE OR DATE OF THE PATIENT'S DEATH." }, { "mdr_text_key": "13448958", "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 COMPLICATION(S) EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY OF UNKNOWN CAUSE AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S BOWEL INJURY IS 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": "" } ] }