{ "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": "I", "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": "2955842-2018-10774", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181220", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20181220", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1026890", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181220", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "DA VINCI XI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS4001-01", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "TX", "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": "20181220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Adhesion(s)" ] } ], "distributor_city": "", "date_report": "20181211", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8187373", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181211", "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": "131141008", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE ALLEGED POST-OPERATIVE COMPLICATION SUSTAINED BY THE PATIENT. THE DATE THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT CAME BACK TO THE HOSPITAL AND HER BOWEL WAS FOUND TO BE STUCK TO THE PELVIC WALL. AS A RESULT, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE TO HAVE THE BOWEL DISSECTED OFF OF THE PELVIC WALL. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "131141009", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND THE PATIENT WAS DISCHARGED, THE PATIENT¿S BOWEL WAS FOUND TO BE STUCK TO THE ABDOMINAL WALL. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE TO TAKE DOWN THE BOWEL USING BLUNT DISSECTION. THERE WAS NO REPORT OF A BOWEL PERFORATION. THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. ON 12/13/2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED FROM AN ISI CLINICAL TERRITORY ASSOCIATE (CTA): THE CTA WAS PRESENT DURING THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE CASE WAS COMPLETED ROBOTICALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT DEVELOPED UNSPECIFIED SYMPTOMS AND UNDERWENT AN UNSPECIFIED NON-ROBOTIC SURGICAL PROCEDURE TO TAKE DOWN THE BOWEL WHICH WAS FOUND TO BE STUCK TO THE PELVIC WALL BY THE CUFF CLOSURE. THE CTA SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION. THE SURGEON DID NOT KNOW THE CAUSE OF THE POST-OPERATIVE COMPLICATION." } ], "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": "" } ] }