{ "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": "2955842-2021-11161", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210921", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20210921", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1407773", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210921", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART, 4-ARM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "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": [ "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20210921", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20210828", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12506307", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210828", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "272493428", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S OPERATIVE COMPLICATION IS UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A SYSTEM LOG REVIEW CANNOT BE PERFORMED AT THIS TIME SINCE THE EVENT DATE, SURGEON NAME, SITE NAME, AND DA VINCI SYSTEM INFORMATION ARE UNCONFIRMED AT THIS TIME. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE, VARIOUS COMPLICATIONS ASSOCIATED WITH ROBOTIC PROCEDURES WERE NOTED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE COMPLICATIONS AS WELL AS THE MEDICAL/SURGICAL INTERVENTION RENDERED, IF ANY, ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "272493429", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 08/28/2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A WORLD JOURNAL OF UROLOGY ARTICLE TITLED, ¿NEW TECHNIQUE OF ROBOT-ASSISTED LAPAROSCOPIC ARTIFICIAL URINARY SPHINCTER IMPLANTATION IN FEMALE BY A POSTERIOR APPROACH WITH INTRAOPERATIVE CYSTOSCOPIC MONITORING¿ (BROUDEUR, L., LOUBERSAC, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: \"TWENTY-FOUR PATIENTS WERE INCLUDED, THE MEDIAN AGE WAS 66 YEARS, 23/24 (96%) HAD PREVIOUS STRESS URINARY INCONTINENCE (SUI) OR PROLAPSE SURGERY. TWO CONVERSIONS TO OPEN SURGERY DUE TO MAJOR PELVIC ADHESIONS AND POOR RESPIRATORY TOLERANCE TO PNEUMOPERITONEUM. 2 PATIENTS UNDERWENT MODIFICATIONS OF THE SURGICAL TECHNIQUE WITH ANTERIOR DISSECTION OF THE BLADDER NECK DUE TO MAJOR VESICOVAGINAL ADHESIONS. OVERALL, 20 PATIENTS UNDERWENT THE ROBOTIC POSTERIOR APPROACH. ELEVEN INTRAOPERATIVE COMPLICATIONS IN 10 PATIENTS (50%) OCCURRED, INCLUDING 7 BLADDER INJURIES , 4 VAGINAL INJURIES, WITHOUT THE NEED TO STOP THE PROCEDURE. THE MEDIAN HOSPITAL STAY WAS 3 DAYS (2¿7). ONE ARTIFICIAL URINARY SPHINCTER (AUS) WAS REMOVED AT 1 YEAR DUE TO VAGINAL EROSION.\" ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }