{ "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": "HOSPITAL", "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": "2955842-2015-00804", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150529", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "Foreign", "Literature", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150529", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "348564", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150529", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "", "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" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20150529", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Fistula", "Hematoma", "Tissue Damage", "Injury", "Disability", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20150504", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4805415", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150504", "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": "5919998", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE SURGICAL ENDOSCOPY JOURNAL ARTICLE TITLED, ROBOT-ASSISTED LAPAROSCOPY FOR DEEP INFILTRATING ENDOMETRIOSIS: INTERNATIONAL MULTICENTRIC RETROSPECTIVE STUDY (COLLINET, ET AL., 2014). IN THE RESULTS SECTION OF THE JOURNAL ARTICLE, THE FOLLOWING WAS NOTED: IN THE RECTUM GROUP, 79% (37/47) OF THE PATIENTS HAD GASTROINTESTINAL SYMPTOMS COMPARED WITH 21% (10/47) OF THE PATIENTS WHO HAD NO GASTROINTESTINAL DISORDERS (P = 1.4.10-9). THE MAIN COMPLICATIONS EXPERIENCED IN THIS GROUP ARE LISTED IN TABLE 2. A LAPAROTOMY CONVERSION WAS PERFORMED DURING A SEGMENTAL RECTAL RESECTION. TWO RECTAL INJURIES OCCURRED DURING RECTAL SHAVING. THE ONE WAS SUTURED, AND THE OTHER NEEDED A SEGMENTAL RECTAL RESECTION WITHOUT STOMIA. THE PATIENTS HAD NO FISTULAS OR ABSCESSES. THIS GROUP ALSO HAD INCREASED BLOOD LOSS (127.5 ± 293 ML; MEDIAN 30 ML; RANGE 5-2, 300 ML) AND ONE CASE OF SEVERE BLEEDING (2,300 ML) DURING A BOWEL RESECTION, REQUIRING BLOOD TRANSFUSION. IN THE BLADDER GROUP, 55% (11/20) OF THE PATIENTS HAD URINARY SYMPTOMS COMPARED WITH 21% [SIC] (9/20) OF THE PATIENTS WITHOUT URINARY DISORDERS (P=0.27). THE COMPLICATIONS IN THIS GROUP INCLUDED A VESICOVAGINAL HEMATOMA AFTER A PARTIAL CYSTECTOMY [SIC] AND ONE PATIENT WHO REQUIRED INTERMITTENT SELF-CATHETERIZATION FOR 6 MONTHS. NO REOPERATIONS OR FISTULAS OCCURRED. IN THE URETER AND UTEROSACRAL LIGAMENTS GROUP (115 PATIENTS), TWO URETERAL FISTULAS OCCURRED. THIS FIRST CASE OCCURRED AFTER RECTAL SHAVING AND URETEROLYSIS, AND THE SECOND CASE OCCURRED AFTER A PARTIAL CYSTECTOMY AND URETEROVESICAL REIMPLANTATION. IN THE LATTER CASE, A WOUND DEHISCENCE REQUIRED A SECOND URETEROVESICAL REIMPLANTATION." }, { "mdr_text_key": "13411251", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENTS. THERE IS NO ALLEGATION IN THE JOURNAL ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. ISI HAS ATTEMPTED TO CONTACT ONE OF THE AUTHORS OF THE JOURNAL ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE FOLLOWING INFORMATION IS UNKNOWN: THE NAME OF THE HOSPITAL WHERE THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, AND THE DATE OF THE PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE JOURNAL ARTICLE, MULTIPLE PATIENTS EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN." } ], "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": "" } ] }