{ "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": "2955842-2022-11152", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220420", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220304", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20220420", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190410", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1266646", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220420", "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": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/22/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20220420", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "75 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220322", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14163692", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220322", "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": "294608701", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A COMPLETED SLEEP ENDOSCOPY + MODIFIED UVULOPHARYNGOPALATOPLASTY (UPPP) + TONSILLECTOMY, BILATERAL + (SINGLE PORT, SP) ROBOT ASSISTED EXCISION OF LESION OF TONGUE (GRADE 1) IN A PARTICIPANT OF THE SP-TRANSORAL ROBOTIC SURGERY (TORS) OBSTRUCTIVE SLEEP APNEA (OSA) STUDY, THE PATIENT DEVELOPED ORAL BLEEDING ON THE 9TH POST-OPERATIVE DAY (POD). THE BLEEDING WAS INITIALLY TREATED WITH ICE WATER GARGLING AND FASTING, BUT THE ORAL BLEEDING PERSISTED. A TONGUE BASE HEMATOMA WAS FOUND ON PHYSICAL EXAMINATION AND THE PATIENT UNDERWENT A SECOND PROCEDURE UNDER GENERAL ANESTHESIA TO LIGATE THE BLEEDING VESSEL. THE BLEEDING WAS FOUND TO BE OOZING. DUE TO THIS ADVERSE EVENT, THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. IT WAS NOTED BY THE SURGEON THAT BLEEDING AFTER PROCEDURES IS EXPECTED AND NORMAL FOR PATIENTS WITH OSA SURGERY, AND THIS EVENT WAS NOT CAUSED OR INDUCED BY A MEDICAL DEVICE MALFUNCTION OR USE. THE PATIENT RECOVERED AFTER THE SECOND PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE UPPP AND BILATERAL TONSILLECTOMY WAS CARRIED OUT VIA TRADITIONAL METHOD BY HAND. THE TONGUE WAS RESECTED AS THE LESION CAUSED ORAL BLEEDING. THERE WAS NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT OR ACCESSORY. THE BLEEDING WAS NOT CAUSED BY ANY ANATOMICAL FACTORS OF MEDICAL HISTORY IN THE PATIENT. THE BLEEDING OCCURRED FROM THE TONGUE AND THE AMOUNT OF BLOOD LOSS AS 10 ML. THE SURGEON BELIEVES THE CAUSE OF THE BLEEDING WAS NORMAL BLEEDING AFTER THE PROCEDURE. THERE ARE NO PHOTOGRAPHS OR VIDEOS OF THE PROCEDURE AVAILABLE FOR REVIEW. NO INSTRUMENTS WERE RETURNED TO ISI AS THERE WERE NO KNOWN ASSOCIATED INSTRUMENT MALFUNCTIONS." }, { "mdr_text_key": "294608702", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON STATED THAT THE CAUSE OF THE POST-OPERATIVE BLEEDING IS \"NORMAL BLEEDING AFTER A PROCEDURE\" AND NOT DUE TO A MEDICAL DEVICE (MALFUNCTION OR USE). THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES AND A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A SLEEP ENDOSCOPY + MODIFIED UPPP + TONSILLECTOMY, BILATERAL + (SP) ROBOT-ASSISTED EXCISION OF LESION OF TONGUE (GRADE 1) IN A PARTICIPANT OF THE SP-TORS OSA STUDY, THE PATIENT DEVELOPED ORAL BLEEDING ON THE POD #9. THE BLEEDING WAS INITIALLY TREATED WITH ICE WATER GARGLING AND FASTING, BUT THE ORAL BLEEDING PERSISTED. A TONGUE BASE HEMATOMA WAS FOUND ON PHYSICAL EXAMINATION AND THE PATIENT UNDERWENT A SECOND PROCEDURE UNDER GENERAL ANESTHESIA TO LIGATE THE BLEEDING VESSEL. DUE TO POST-OPERATIVE COMPLICATION, THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. THERE WAS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THE SURGEON STATED THAT THE BLEEDING WAS RELATED TO THE PROCEDURE AND NOT DUE TO A MEDICAL DEVICE ISSUE." }, { "mdr_text_key": "329099938", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329099939", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G3, G6, H2, AND H10. CORRECTED INFORMATION CAN BE FOUND IN SECTION G3." } ], "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": "04/20/2022" } ] }