{ "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": "2955842-2015-01048", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150730", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20150630", "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": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150730", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "496387", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150730", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": [ "Inadequate or Insufficient Training" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": [ "Life Threatening", " R" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Perforation", "Tissue Damage", "Uterine Perforation", "Perforation of Vessels", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20150630", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4953845", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150630", "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": "6635016", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, BLEEDING WAS OBSERVED AFTER SUTURATION OF THE VAGINAL STUMP WAS COMPLETED. IN ORDER TO CONTROL THE BLEEDING AND PER THE RECOMMENDATION FROM THE ANESTHETIST, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI HYSTERECTOMY TO OPEN SURGERY. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE PATIENT HAD CHRONIC VALVULAR DISEASE. BASED ON ECHOCARDIOGRAM RESULTS, THE ANESTHETIST DETERMINED THAT THE PATIENT COULD ONLY TOLERATE A HEAD-DOWN TILT POSITION OF NO GREATER THAN 10 DEGREES. THE CSR INDICATED THAT OPEN SURGERY WAS NOT AN OPTION. THE SURGEON CHOSE TO PERFORM THE SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM INSTEAD OF TRADITIONAL LAPAROSCOPIC SURGERY. DURING THE DA VINCI SURGERY, AN ASSISTANT DOCTOR MISTAKENLY PIERCED OR PERFORATED THE PATIENT'S UTERUS WHILE INSERTING A MANIPULATOR INSTRUMENT, A NON-ISI DEVICE. DUE TO THE INJURY TO THE UTERUS AND THE LIMITED VISION OF THE SURGICAL FIELD IN RELATION TO THE 10 DEGREE HEAD-DOWN TILT POSITION, THE SURGEON INDICATED THAT THE SURGICAL PROCEDURE BECAME MORE DIFFICULT TO PERFORM. AFTER REMOVING THE UTERUS AND SUTURING THE VAGINAL STUMP, BLEEDING WAS OBSERVED IN MULTIPLE LOCATIONS BETWEEN THE RECTUM AND VAGINA. THE CSR BELIEVED THE SOURCE OF THE BLEEDING WERE VESSEL PERFORATIONS OR TEARS. HOWEVER, THE ACTUAL SOURCE OF THE BLEEDING IS UNCLEAR. THE SURGEON APPLIED FIBRIN SEALANT BUT WAS UNABLE TO ACHIEVE HEMOSTASIS. THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP INTO THE 40'S AND THE ESTIMATED BLOOD LOSS WAS OVER 2500 CC. CARDIAC COMPRESSIONS WERE ADMINISTERED. IN ORDER TO CONTROL THE BLEEDING THE SURGEON MADE THE DECISION TO CONVERT THE CASE TO OPEN SURGERY. THE PATIENT RECEIVED BLOOD TRANSFUSIONS AND THE SURGICAL PROCEDURE WAS COMPLETED. ACCORDING TO THE CSR, THE SURGEON COMMENTED THAT THE INTRA-OPERATIVE BLEEDING WAS CAUSED BY HIS OWN LACK OF EXPERIENCE ALTHOUGH HE HAD INSISTED ON PERFORMING THE SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM AND WITH LIMITED VISIBILITY OF THE SURGICAL FIELD IN RELATION TO PATIENT POSITIONING. THE SURGEON INDICATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "14310233", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SURGEON INDICATED THAT THE INTRA-OPERATIVE BLEEDING WAS CAUSED BY HIS LACK OF EXPERIENCE AND THE DIFFICULTY OF THE CASE DUE TO THE LIMITED VISION OF THE SURGICAL FIELD IN RELATION TO PATIENT POSITIONING. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATIONS. 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 EXPERIENCED AN ESTIMATED BLOOD LOSS OF OVER 2500 CC WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, AND REQUIRED CHEST COMPRESSIONS AND BLOOD TRANSFUSIONS. HOWEVER, THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS CAN BE ATTRIBUTED TO SURGEON ERROR AND POOR PATIENT SELECTION." } ], "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": "" } ] }