{ "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": "Death", "report_number": "2955842-2014-05786", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141204", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120119", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141204", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "782772", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141204", "brand_name": "DA VINCI SI 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": "IS3000", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20141204", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "67", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Airway Obstruction", "Cardiopulmonary Arrest", "Death", "Dysphagia/ Odynophagia", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Anxiety" ] } ], "distributor_city": "", "date_report": "20141104", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4298433", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141104", "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": "20948463", "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 PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT'S DEMISE WAS RELATED TO THE DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "20781540", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A SLEEP NASAL ENDOSCOPY, UVULOPALATOPHARYNGOPLASTY AND TONGUE BASE REDUCTION WITH DA VINCI TRANSORAL ROBOTIC SURGERY (TORS) PROCEDURE ON (B)(6) 2012 FOR SEVERE OBSTRUCTIVE SLEEP APNEA AND CPAP INTOLERANCE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, THE PATIENT WAS FOUND TO HAVE PROFOUND LINGUAL TONSIL HYPERPLASIA WHICH LED TO IMMEDIATE UPPER AIRWAY OBSTRUCTION UPON LOW DOSE ADMINISTRATION OF PROPOFOL. TO A LESSER EXTENT, THE PATIENT HAD UVULA AND SOFT PALATAL COLLAPSE. A TOTAL OF 19 ML OF TONGUE BASE WAS REMOVED. AS HEMOSTATIC AGENT WAS BEING APPLIED, BRISK BLEEDING WAS NOTED IN THE LEFT HYPOPHARYNX AND A THROAT PACK WAS PLACED. AFTER ALLOWING ADEQUATE TIME FOR HEMOSTASIS, THE THROAT PACK WAS GRADUALLY ADVANCED OUT OF THE HYPOPHARYNX AND EXPOSURE WAS ACHIEVED WITH A MOUTH GAG AND ROBOTIC CAMERA. THE SURGEON NOTED THAT THE LIKELY SOURCE OF BLEEDING WAS A SMALL BRANCH OF THE LINGUAL ARTERY, AND THIS WAS CONTROLLED WITH HEMOCLIPS. THE SURGERY CONTINUED TO COMPLETION, WITH AN ESTIMATED BLOOD LOSS OF 300 ML. FOLLOWING THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTERMEDIATE CARE UNIT FOR AIRWAY OBSERVATION AND PAIN CONTROL. PER AN OFFICE NOTE DATED (B)(6) 2012, THE HOSPITAL NUTRITIONIST REPORTED TO THE SURGEON THAT THE PATIENT COULD NOT SWALLOW ANY LIQUIDS AND WAS GETTING UPSET. THE PATIENT FELT THAT SHE COULD NOT MOVE THE FOOD DOWN AND IT WAS STAYING ON THE BASE OF HER TONGUE. THE PATIENT WAS NOTED TO BE PANICKY AND ANXIOUS. THE PATIENT WAS ADVISED TO CONTINUE WITH ICE CHIPS AND ICE POPS. THE ROLE OF A TEMPORARY FEEDING TUBE WAS DISCUSSED WITH THE PATIENT'S HUSBAND ONLY IN THE EVENT OF AN EXTREME CASE OF DYSPHAGIA. ON (B)(6) 2012, THE PATIENT WAS NOTED TO HAVE DIFFICULTY SWALLOWING AND OCCASIONAL COUGHING. AN ATTEMPT WAS MADE TO PLACE A FEEDING TUBE UNDER DIRECT VISUALIZATION. HOWEVER, THE FEEDING TUBE PLACEMENT WAS UNSUCCESSFUL DUE TO THE PATIENT GAGGING. ON NASOPHARYNGOLARYNGOSCOPE, THERE WERE NO POOLED SECRETIONS IN THE HYPOPHARYNX, OR CLOTS OR BLEEDING FOUND. THERE WAS A NORMAL APPEARING BLACK ESCHAR IN THE AREA OF THE RESECTION. LATER THAT DAY, THE PATIENT WAS NOTED TO HAVE MADE A MARKED IMPROVEMENT IN HER ABILITY TO TOLERATE A LIQUID DIET PER A VERBAL REPORT BY A NURSE, AND SHE HAD AN UNEVENTFUL NIGHT. ON (B)(6) 2012 AT APPROXIMATELY 8:50 AM, THE PATIENT WAS WITNESSED TO HAVE SIGNIFICANT BLEEDING FROM THE ORAL CAVITY AND A CODE BLUE WAS CALLED. HER AIRWAY WAS SECURED WITH A BEDSIDE TRACHEOTOMY WITHIN MINUTES AFTER THE CODE WAS CALLED. OROPHARYNGEAL BLEEDING WAS SUCCESSFULLY CONTROLLED WITH A THROAT PACK, AND RESUSCITATIVE EFFORTS CONTINUED FOR APPROXIMATELY ONE HOUR. THE PATIENT WAS PRONOUNCED DEAD AT 10:11 AM, WITH THE ULTIMATE CAUSE OF DEATH NOTED AS CARDIOPULMONARY ARREST. NO AUTOPSY WAS PLANNED AND THE PATIENT'S BODY WAS NOTED AS ON HOLD FOR ORGAN DONATION. THE DATE OF LAST MEDICAL RECORD PROVIDED WAS (B)(6) 2012." } ], "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": "" } ] }