{ "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": "Injury", "report_number": "2955842-2014-05861", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141212", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20141112", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141212", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "807606", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141212", "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": [ "Positioning Problem" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20141212", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Low Blood Pressure/ Hypotension", "Pain", "Sepsis", "Septic Shock", "Tachycardia", "Injury" ] } ], "distributor_city": "", "date_report": "20141114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4326581", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141114", "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": "5243529", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (LAVH-BSO) AND SUBURETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT SUSTAINED A BOWEL INJURY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT WAS FOUND TO HAVE MULTIPLE ADHESIONS IN THE SMALL BOWEL AND OMENTUM. THE PATIENT DID NOT TOLERATE STEEP TRENDELENBURG POSITIONING; THEREFORE, THE PROCEDURE WAS PERFORMED IN MODERATE TRENDELENBURG POSITIONING. THE SURGEON INDICATED THAT THIS POSITIONING MADE THE SURGERY MORE DIFFICULT TO PERFORM DUE TO HAVING TO PUSH BOWEL AWAY. POST-OPERATIVELY, THE PATIENT HAD MINIMAL URINE OUTPUT AND COMPLAINTS OF INCREASING PAIN. THE PATIENT BECAME HYPOTENSIVE AND TACHYCARDIC WITH ELEVATED WBC AND CREATININE LEVELS. THE PATIENT RETURNED TO THE OR AND UNDERWENT AN EXPLORATORY LAPAROTOMY. THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ENTEROTOMY RESULTING IN SEPTIC SHOCK AND AN INTRA-ABDOMINAL ABSCESS. THE ABSCESS WAS DRAINED AND THE ENTEROTOMY WAS REPAIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER, THE INITIAL REPORTER OF THIS COMPLAINT, AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE RISK MANAGER INDICATED THAT THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER SPOKE TO THE SURGEON DIRECTLY AND WAS INFORMED THAT THERE WERE NO ISSUES WITH THE DA VINCI SURGICAL SYSTEM. THE PATIENT WAS NOTED TO HAVE MULTIPLE ADHESIONS. THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INTRA-OPERATIVE COMPLICATIONS REPORTED. POST-OPERATIVELY, THE PATIENT DEVELOPED SYMPTOMS INDICATIVE OF SEPSIS. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM THE SAME DAY ((B)(6) 2014) AND WAS FOUND TO HAVE 2 SMALL BOWEL ENTEROTOMIES. THE RISK MANAGER WAS UNABLE TO PROVIDE A DESCRIPTION OF THE ENTEROTOMIES. BOTH ENTEROTOMIES WERE REPAIRED WITH SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 TO A NURSING HOME. ACCORDING TO THE RISK MANAGER, THE SURGEON ATTRIBUTED THE ENTEROTOMIES TO THE EXTENSIVE ADHESIONS THAT THE PATIENT HAD." }, { "mdr_text_key": "12704722", "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 INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THE SURGEON ATTRIBUTED THE BOWEL INJURIES TO THE PATIENT'S EXTENSIVE ADHESIONS. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. A SYSTEM ERROR CODE 23075 WAS FOUND TO HAVE OCCURRED ABOUT AN HOUR INTO THE SURGICAL PROCEDURE. A SYSTEM ERROR CODE 23075 INDICATES THAT THE SYSTEM DETECTED CONDITIONS CONSISTENT WITH THE MASTER TOOL MANIPULATOR (MTM) DRIFTING WHILE THE SURGEON'S HEAD IS IN THE CONSOLE. THIS IS TYPICALLY CORRELATED TO THE SURGEON'S HANDS NOT BEING ON THE MASTERS WHILE IN NORMAL SURGICAL MODE AND IS IN PLACE TO PREVENT THIS TYPE OF USER ERROR. THIS ERROR CODE IS NOT LIKELY TO BE RELATED TO THE COMPLAINT AND SHOWS THAT THE SYSTEM IS WORKING AS INTENDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED 2 SMALL BOWEL INJURIES WHILE UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. AT THIS TIME, THE CAUSE OF THE BOWEL INJURIES 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": "" } ] }