{ "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": "2955842-2013-04938", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120321", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562162", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": "20250804", "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "79", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dyspnea", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444201", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "15931032", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S TRANSORAL ROBOTIC SURGERY WITH PARTIAL PHARYNGECTOMY, RADICAL TONSILLECTOMY, AND PARTIAL GLOSSECTOMY FOR SQUAMOUS CELL CARCINOMA OF THE RIGHT OROPHARYNX ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012, NURSING ASSESSMENT OF PT. DISCHARGE READINESS (B)(6) 2012, 2 HANDWRITTEN POSTOPERATIVE PROCEDURE NOTES (B)(6) 2012, PROGRESS NOTE (B)(6) 2012 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. A MCGIVER MOUTH PROP WAS PLACED AND SUSPENDED FROM THE SUSPENSION ARM, THE ROBOT DOCKED WITH THE CAMERA ARM AND 2 OPERATING ARMS POSITIONED APPROPRIATELY, LOADED WITH THE MARYLAND GRASPER, THE MONOPOLAR CAUTERY, AND THE 8MM CAMERA. THE TUMOR WAS IMMEDIATELY VISUALIZED AND REVEALED A > 2CM ENDOPHYTIC TUMOR FROM THE RIGHT TONSIL, COMPLETELY CONFINED TO TONSIL. THE RESECTION WAS THEN INITIATED BY USING THE MONOPOLAR CAUTERY AT THE TONGUE BASE, THE LATERAL PHARYNGEAL WALL, DOWN TO THE MEDIAL PTERYGOID MUSCLE AND THE FAT PAD COVERING THE INTERNAL CAROTID ARTERY. FURTHER DEEP DISSECTION WAS CARRIED DEEP TO THE MUSCLE OF THE SOFT PALATE, PRESERVING THE NASOPHARYNGEAL MUCOSA OF THE SOFT PALATE AND DELIVERING THE RADICAL RESECTION INTO THE MOUTH. THE SPECIMEN WAS THEN REMOVED. ANOTHER INFERIOR MARGIN WAS TAKEN AFTER A RAPID FROZEN SECTION EVALUATION. THE MOUTH PROP WAS SLOWLY RELEASED AND REMOVED AND NO ACTIVE BLEEDING WAS NOTED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 AFTER AN UNEVENTFUL POSTOPERATIVE COURSE. ON 03/24/2012 THE PATIENT WAS BROUGHT BY EMS TO THE ER WITH PRONOUNCED BLEEDING FROM HIS MOUTH THAT STARTED IN THE MORNING. HE HAD BEEN COUGHING A LOT LATELY AND HAS BEEN QUITE CONGESTED FROM THE ALLERGENS AND ALSO FROM THE SURGERY. HE WAS NOT COUGHING AT THE TIME OF THE BLEEDING. PER EMS REPORT, THERE WAS APPROXIMATELY 2 LITERS OF BLOOD LOSS IN THE HOUSE, AND HE HAS HAD PERSISTENT BLEEDING UPON PRESENTATION TO THE HOSPITAL. ON (B)(6) 2012 HE WAS TAKEN BACK TO THE OPERATING ROOM. AN EXAM UNDER ANESTHESIA OF THE OROPHARYNX WITH CONTROL OF BLEEDING AND A DIRECT LARYNGOSCOPY WAS PERFORMED. AN ACTIVE BLEEDING SITE DEEP AT THE GLOSSOTONSILLAR SULCUS/RIGHT LATERAL HYPOPHARYNGEAL WALL WAS IDENTIFIED AND APPEARED TO BE ARTERIAL IN NATURE. INITIAL ATTEMPTS TO CAUTERIZE THIS WITH THE SUCTION BOVIE WERE UNSUCCESSFUL, BUT BY MEANS OF A COBLATOR DEVICE THE BLEEDING WAS CONTROLLED. DUE TO THE DEPTH OF THE BLEEDING SITE, IT WAS IMPOSSIBLE TO PLACE A SUTURE IN THIS AREA FROM THE TRANSORAL APPROACH. BECAUSE OF THE HIGH RISK FOR RECURRENT BLEEDING AT THIS SITE THE PATIENT WAS REFERRED THE SAME DAY TO THE INTERVENTIONAL RADIOLOGIST FOR A CT ANGIOGRAM AND SELECTIVE EMBOLIZATION OF THE FACIAL AND LINGUAL ARTERIES. DURING THE PROCEDURE, LARGE LINGUAL AND FACIAL ARTERY BRANCHES WERE FOUND ON THE RIGHT, THE FACIAL ARTERY ANGIOGRAM DEMONSTRATED AREAS OF TUMOR BLUSH AND GELFOAM SLURRY WAS USED TO SUCCESSFULLY EMBOLIZE THE FACIAL AND THE ENTIRE LINGUAL ARTERY. IN THE MORNING OF POSTOPERATIVE DAY ONE THE PATIENT WAS STILL INTUBATED, BUT ALERT WITH STABLE VITAL SIGNS AND NO SIGNS OF BLEEDING. THE PLAN WAS MADE TO EXTUBATE AND POTENTIALLY DISCHARGE THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THIS DATE." }, { "mdr_text_key": "15985199", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE." } ], "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": "" } ] }