{ "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": "", "report_to_fda": "", "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": "Injury", "report_number": "MW5190265", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260706", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260318", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "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": "20260707", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "403044", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260706", "brand_name": "DA VINCI ROBOT", "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT", "manufacturer_d_name": "INTUITIVE SURGICAL, 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": "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" } } ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20260814", "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": "20260706", "sequence_number_treatment": [ "DIAZEPAM TABLETS", " ESCITALOPRAM TABLETS", " LIPITOR TABLETS", " LOSARTAN TABLETS", " TYLENOL TABLETS" ], "sequence_number_outcome": [ "Disability", " O", " L", " H" ], "patient_age": "73 YR", "patient_sex": "Male", "patient_weight": "69 KG", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "Abdominal Pain", "Diarrhea", "Emotional Changes", "Fever", "Unspecified Infection", "Nausea", "Pain", "Sepsis", "Vomiting", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20260627", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "25718452", "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": "406658588", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MEDICAL MALPRACTICE LINKS TO SURGICAL ERROR, MISUSED OF DA VINCI ROBOT, INADEQUATE PATIENT MONITORING, DELAYED DIAGNOSIS AND TREATMENT, SEPSIS. ON (B)(6) 2026, I UNDERWENT WHAT WAS SUPPOSED TO BE A ROUTINE LEFT INGUINAL HERNIA REPAIR AT (B)(6) HOSPITAL. AFTER SURGERY, I WAS DISCHARGED HOME THE FOLLOWING DAY BELIEVING EVERYTHING HAD GONE WELL. OVER THE NEXT SEVERAL DAYS, MY CONDITION RAPIDLY WORSENED. I BEGAN EXPERIENCING SEVERE ABDOMINAL PAIN, NAUSEA, VOMITING, DIARRHEA, FEVER, CHILLS, AND I BECAME UNABLE TO EAT OR DRINK PROPERLY. MY SYMPTOMS CONTINUED TO INTENSIFY, AND BY (B)(6) 2026, I RETURNED TO THE EMERGENCY ROOM IN CRITICAL CONDITION. EMERGENCY ROOM DOCTORS DISCOVERED THAT MY BOWEL HAD BEEN ACCIDENTALLY PUNCTURED DURING THE ORIGINAL HERNIA SURGERY AND THAT THE PERFORATION HAD NOT BEEN IMMEDIATELY RECOGNIZED OR TREATED. BECAUSE THE BOWEL PERFORATION WENT UNDIAGNOSED FOR SEVERAL DAYS, INFECTION SPREAD THROUGHOUT MY ABDOMEN, LEADING TO ABDOMINAL SEPSIS AND A LIFE-THREATENING EMERGENCY. ON (B)(6) 2026, I UNDERWENT EMERGENCY SURGERY TO REMOVE THE DAMAGED SECTION OF INTESTINE AND CONTROL THE INFECTION. I REQUIRED EXTENSIVE TREATMENT INCLUDING IV ANTIBIOTICS, IV FLUIDS, URINARY CATHETERIZATION, A WOUND VACUUM, AND AN ILEOSTOMY BAG. I REMAINED HOSPITALIZED FOR ONE WEEK RECOVERING FROM SEVERE COMPLICATIONS CAUSED BY DELAYED DIAGNOSIS AND TREATMENT OF BOWEL PERFORATION. EVEN AFTER DISCHARGE, MY RECOVERY CONTINUED WITH SIGNIFICANT PHYSICAL PAIN, EMOTIONAL TRAUMA, ONGOING WOUND CARE, NURSING CARE, ILEOSTOMY CARE, AND THE NEED FOR FUTURE SURGERY TO REVERSE THE ILEOSTOMY. \"BOWEL PERFORATION CAUSED BY THE ROBOT?\"" } ], "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": "" } ] }