{ "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": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "MW5064171", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20160814", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20160811", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT FAMILY MEMBER OR FRIEND", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20160819", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "526705", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160814", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE MEDICAL INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "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": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "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": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20160814", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Pain", "Perforation", "Respiratory Distress", "Septic Shock", "Loss of consciousness", "Death", "Pain", "Perforation", "Respiratory Distress", "Septic Shock", "Loss of consciousness" ] } ], "distributor_city": "", "date_report": "20160816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5888295", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary 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": "52622126", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX 9:45PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT ARE DONE WITH NORMAL LAPAROSCOPIC SURGERY WITH NO ROBOT. IT IS MY UNDERSTANDING THAT IT HAPPENS A LOT MORE OFTEN WITH THE DA VINCI ROBOT AND IS UNDER REPORTED! THIS NEEDS TO BE INVESTIGATED ASAP AND IT REPRESENTS AN IMMEDIATE DANGER TO THE PUBLIC AT LARGE! MY SISTER HAS NO CHILDREN BUT SHE DID HAVE FAMILY WHO LOVED HER AND MANY STUDENTS WHO SHE TAUGHT WHO LOVED HER. THIS SHOULD NOT HAVE HAPPENED TO HER AND THE FDA NEEDS TO TAKE IMMEDIATE ACTION TO PRESENT IT FROM HAPPENING TO SOMEONE ELSE." } ], "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": "" } ] }