{ "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": "MW5184473", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260226", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240415", "reprocessed_and_reused_flag": "", "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": "20260302", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "513386", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260226", "brand_name": "DA VINCI SURGICAL SYSTEM", "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": "", "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": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20260303", "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": "20260226", "sequence_number_treatment": [ "BLACK SEED OIL.", " GINGER.", " IRON.", " METFORMIN.", " TURMERIC.", " VITAMIN D." ], "sequence_number_outcome": [ "Life Threatening", " H", " O", " S", " R" ], "patient_age": "46 YR", "patient_sex": "Female", "patient_weight": "86 KG", "patient_ethnicity": "", "patient_race": "Black Or African American", "patient_problems": [ "Unspecified Infection", "Sepsis", "Anxiety", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "date_report": "20260222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "24460961", "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": "394288007", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DESCRIPTION OF EVENT ON (B)(6) 2024, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARTIAL HYSTERECTOMY UTILIZING THE DA VINCI ROBOTIC SURGICAL SYSTEM AT (B)(6) MEDICAL CENTER IN (B)(6). FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SEVERE AND LIFE-THREATENING POSTOPERATIVE COMPLICATIONS, INCLUDING: SEPSIS, MULTIPLE ORGAN DAMAGE, SEVERE INFECTION LEADING CHRONIC LONG-TERM INFECTIONS, PROLONGED HOSPITALIZATION, ADDITIONAL SURGEONS, COVERING 4 MAJOR BODY SYSTEMS, PERMANENT PHYSICAL IMPAIRMENT AND SEVERE EMOTIONAL MEDICAL ANXIETY. THE SEVERITY AND PROGRESSION OF THESE COMPLICATIONS RAISES SIGNIFICANT CONCERNS REGARDING POTENTIAL DEVICE-RELATED INJURY, DELAYED RECOGNITION OF INTRAOPERATIVE INJURY, OR POSSIBLE MALFUNCTION OR LIMITATIONS ASSOCIATED WITH THE ROBOTIC SURGICAL SYSTEM. DEVICE-RELATED CONCERNS BASED ON MEDICAL RECORDS AND POSTOPERATIVE CLINICAL COURSE, THE FOLLOWING CONCERNS REQUIRE INVESTIGATION: 1. POSSIBLE DEVICE MALFUNCTION THERE IS CONCERN THAT THE DA VINCI ROBOTIC SURGICAL SYSTEM MAY HAVE EXPERIENCED MALFUNCTION, CALIBRATION ERROR, OR MECHANICAL OR SOFTWARE-RELATED PERFORMANCE ISSUES DURING THE PROCEDURE. 2. INADEQUATE VISUALIZATION THERE IS CONCERN THAT VISUALIZATION PROVIDED BY THE ROBOTIC SYSTEM MAY HAVE BEEN INADEQUATE TO IDENTIFY INTRAOPERATIVE INJURY, CONTRIBUTING TO DELAYED RECOGNITION OF COMPLICATIONS. 3. DELAYED RECOGNITION OF INJURY THERE IS CONCERN THAT INJURY OCCURRING DURING ROBOTIC SURGERY WAS NOT IMMEDIATELY RECOGNIZED INTRAOPERATIVELY, RESULTING IN DELAYED TREATMENT AND WORSENING OF THE PATIENT'S CONDITION. 4. IMPROPER OPERATION OR SYSTEM USE INVESTIGATION IS REQUESTED TO DETERMINE WHETHER THE ROBOTIC SYSTEM WAS PROPERLY CONFIGURED, CALIBRATED, AND OPERATED ACCORDING TO MANUFACTURER SAFETY GUIDELINES AND HOSPITAL PROTOCOLS. 5. DEVICE-RELATED OR PROCEDURE-RELATED TISSUE OR ORGAN INJURY THE PATIENT'S POSTOPERATIVE COMPLICATIONS RAISE CONCERN THAT INJURY MAY HAVE OCCURRED DURING ROBOTIC SURGICAL MANIPULATION. 6. LACK OF ADEQUATE WARNING OR SAFEGUARDS INVESTIGATION IS REQUESTED TO DETERMINE WHETHER ALL REQUIRED SAFEGUARDS, WARNINGS, AND RISK DISCLOSURES RELATED TO ROBOTIC SURGERY WERE PROPERLY FOLLOWED. OUTCOME THE PATIENT SUFFERED SEVERE, LIFE-THREATENING COMPLICATIONS RESULTING IN PERMANENT PHYSICAL HARM AND SIGNIFICANT MULTIPLE MEDICAL INTERVENTIONS. REQUEST FOR FDA INVESTIGATION: THIS REPORT IS SUBMITTED TO ENSURE THE FDA IS AWARE OF THIS ADVERSE EVENT AND TO REQUEST EVALUATION OF: DEVICE PERFORMANCE, DEVICE MALFUNCTION RISK, SAFETY PROTOCOLS, MANUFACTURER REPORTING COMPLIANCE, SIMILAR REPORTED ADVERSE EVENTS." } ], "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": "" } ] }