{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2024-20320", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20241007", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240312", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "408", "date_added": "20241007", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2543633", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241007", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "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": "DA", "device_evaluated_by_manufacturer": "N", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/15/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20241007", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240910", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20385586", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240910", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "358157651", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ATTEMPTS WERE MADE TO CONTACT THE DESIGNATED AUTHOR, AND THE AUTHOR COMMENTED THAT THE COMPLICATIONS NOR THE MORTALITIES WERE UNRELATED TO THE DA VINCI DEVICES." }, { "mdr_text_key": "353521832", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. CITATION: MCKAY B, BROUGH D, KILBURN D, CAVALLUCCI D. SAFETY AND FEASIBILITY OF INSTITUTING A ROBOTIC PANCREAS PROGRAM IN THE AUSTRALIAN SETTING: A CASE SERIES AND NARRATIVE REVIEW. ANZ J SURG. 2024 JUL-AUG;94(7-8):1247-1253. DOI: 10.1111/ANS.18998. EPUB 2024 MAR 26. PMID: 38529778. SECTION A - PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THESE PATIENTS. THE MEDIAN AGE OF 68 YEARS FOR THE PD GROUP AND 60 YEARS FOR THE DP GROUP. THE MEDIAN BMI WAS NOT EXPLICITLY STATED IN THE ARTICLE. THE GENDER DISTRIBUTION WAS APPROXIMATELY 46.4% FEMALE AND 53.6% MALE IN THE DP GROUP. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENTS AS MULTIPLE DA VINCI SYSTEMS WERE USED IN THE PROCEDURES, GENERAL DA VINCI SYSTEM WAS USED." }, { "mdr_text_key": "353521833", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING DA VINCI-ASSISTED ROBOTIC DISTAL PANCREATECTOMY (DP) AND PANCREATICODUODENECTOMY (PD) PROCEDURES PERFORMED BY A SINGLE SURGEON, WAS COMPLETED. THE STUDY EVALUATED THE SAFETY AND FEASIBILITY OF INSTITUTING A ROBOTIC PANCREATECTOMY PROGRAM. THE STUDY INCLUDED SURGERIES FROM MAY 2014 TO DECEMBER 2020, DURING WHICH 62 PATIENTS UNDERWENT ROBOTIC PANCREATECTOMY, 34 PATIENTS WERE IN THE PD GROUP AND 28 PATIENTS WERE IN DP GROUP. 13 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY IN PD GROUP DUE TO VEIN RESECTION, BILIOPANCREATIC RESECTION OR DIFFICULT DISSECTION. POST-OPERATIVELY, IN THE PANCREATICODUODENECTOMY (PD) GROUP, NINE PATIENTS (26.5%) EXPERIENCED CLAVIEN-DINDO GRADE III OR MORE COMPLICATIONS COMPARED TO 5 PATIENTS (17.9%) IN THE DISTAL PANCREATECTOMY (DP) GROUP. OF THE 5 GRADE B/C POSTOPERATIVE PANCREATIC FISTULA (POPF) IN THE PD GROUP, 4 PATIENTS REQUIRED OPERATIVE INTERVENTION WHILST ALL OF THOSE IN THE DP GROUP WERE MANAGED EITHER ENDOSCOPICALLY OR WITH PROLONGED USE OF SURGICAL DRAINS. THREE PATIENTS EXPERIENCED POST-PANCREATECTOMY HEMORRHAGE IN PD GROUP WHILE 1 PATIENT IN DP GROUP. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. ATTEMPTS WERE MADE TO COMMUNICATE WITH THE DESIGNATED AUTHOR TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MENTIONED EVENT BUT NO RESPONSE WAS RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/22/2024" } ] }