{ "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": "Death", "report_number": "2955842-2022-11453", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220507", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Study", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220507", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20181005", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1233874", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220507", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601-33", "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": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "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": "20220507", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "63 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20200514", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14325544", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200514", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "291198376", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO ISI FOR EVALUATION. A MEDICAL REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE ARTICLE TITLED ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (K. VAN ABEL, ET AL., 2019) RETROSPECTIVELY REVIEWED A COHORT OF 78 TORS CASES. THERE WERE TWO POST-OPERATIVE MORTALITIES NOTED. ONE DUE TO A POST-OPERATIVE PULMONARY EMBOLISM AND ONE DUE TO A POST-OPERATIVE BLEED. THIS MEDICAL REVIEW WILL FOCUS ON THE POST-OPERATIVE MORTALITY DUE TO POST-TONSILLECTOMY HEMORRHAGE AND SUBSEQUENT MORTALITY. THE AUTHORS OF THE ARTICLE REVIEWED ALL INTRA-OPERATIVE EVENTS DURING THE USE OF THE SP SYSTEM TO PERFORM THE TORS PROCEDURE. THE AUTHORS OF THE ARTICLE DID NOT IDENTIFY ANY INTRA-OPERATIVE COMPLICATIONS OR ANY SYSTEM OR INSTRUMENT RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE PATIENT¿S POST-TONSILLECTOMY HEMORRHAGE AND SUBSEQUENT MORTALITY. ACCORDING THE ARTICLE TITLED ¿ANALYSIS OF POSTOPERATIVE BLEEDING AND RISK FACTORS IN TRANSORAL SURGERY OF THE OROPHARYNX¿: T. POLLEI, M. HINNI, E. MOORE, JAMA OTOLARYNGOLOGY HEAD NECK SURGERY. 2013; 139(11):1212-1218, POSTOPERATIVE BLEEDING OCCURRED IN 5.4% OF PATIENTS (49 OF 906) OF TRANSORAL RESECTIONS OF OROPHARYNGEAL CARCINOMA. SEVERE, OR LIFE-THREATENING HEMORRHAGE OCCURRED IN 1.1.% OF THE PATIENTS IN THE STUDY. TONSILLAR PRIMARY CARCINOMAS WERE MORE LIKELY TO BLEED WHEN COMPARED TO THE TONGUE BASE PRIMARY CARCINOMAS. THE MEAN POSTOPERATIVE DAY OF BLEEDING WAS DAY 10. HIGHER STAGED TUMORS WERE MORE LIKELY TO BLEED. ADDITIONALLY, NOTED IN THE STUDY: ANALYSIS COMPARING DIFFERENT TECHNIQUES DID NOT REVEAL ANY STATISTICAL SIGNIFICANCE BETWEEN THE THREE MODALITIES TLM (TRANSORAL LASER MICROSURGERY, TORS (TRANSORAL ROBOTIC SURGERY) AND HANDHELD MONOPOLAR RESECTIONS. THE POSTOPERATIVE TONSILLECTOMY BLEEDING AND SUBSEQUENT MORTALITY IS DUE TO A DELAYED SEVERE BLEED THAT CAN BE ATTRIBUTED TO THE NATURE OF THE PROCEDURE AND NOT THE MODALITY TO HOW THE PROCEDURE WAS PERFORMED. THE CAUSE OF MORTALITY IS RELATED TO ASPHYXIA DUE TO POSTOPERATIVE BLEEDING. A SYSTEM LOG REVIEW CANNOT BE PERFORMED SINCE NO PROCEDURE DATE WAS PROVIDED. THE EVENT DATE AND DATE OF DEATH ARE KNOWN. NO IMAGES OR VIDEOS WERE SUBMITTED FOR ISI¿S EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED PROCEDURE, THE PATIENT EXPERIENCED A POST-TONSILLECTOMY HEMORRHAGE AND EXPIRED. AT THIS TIME, THE CAUSES OF THE POST-TONSILLECTOMY HEMORRHAGE AND SUBSEQUENT PATIENT DEATH ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #220557 FOR THE PATIENT DEATH NOTED WITHIN THE JOURNAL ARTICLE ASSOCIATED WITH POST-TONSILLECTOMY HEMORRHAGING." }, { "mdr_text_key": "291198377", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 14-MAY-2020, INTUITIVE BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1 %. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. THE ARTICLE¿S CONCLUSION CONTAINS THE FOLLOWING: ¿THERE WERE NO COMPLICATIONS DIRECTLY RELATED TO THE ROBOTIC PLATFORM, MAKING THE SP A SAFE SURGICAL INSTRUMENT FOR UPPER AERODIGESTIVE TRACT TUMORS. ALTHOUGH THE NEW SYSTEM POSED UNIQUE TECHNICAL CHALLENGES, THE OVERALL LEARNING CURVE FOR THE SP WAS RAPID AMONG EXPERIENCED TORS SURGEONS.¿ INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE AUTHOR WHO STATED THE FOLLOWING REGARDING THE REPORTED COMPLICATIONS: THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE SYSTEM OR INSTRUMENT WAS INVOLVED IN THESE COMPLICATIONS. \"THESE ARE KNOWN RISKS WITH THIS SURGICAL PROCEDURE, DOCUMENTED WITH THE SI AND TRANSORAL LASER MICROSURGERY AS WELL. WE DID NOT IDENTIFY A RATE HIGHER THAN THE PUBLISHED AVERAGES.\" NOTE: THIS COMPLAINT WAS CREATED TO LOG 1 OF 2 PATIENT DEATHS. THIS RECORD CAPTURES THE DEATH SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }