{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SUNNYVALE", "manufacturer_contact_address_1": "1266 KIFER RD, BLDG 101", "manufacturer_contact_pcity": "40852324", "event_type": "Death", "report_number": "2955842-2013-02794", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20130729", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130625", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "4085232420", "noe_summarized": "1", "manufacturer_contact_l_name": "REED", "source_type": [ "Other", "User facility", "Company representation", "COMPANY REPRESENTATI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "408", "date_added": "20130729", "manufacturer_contact_f_name": "TABITHA", "device_date_of_manufacturer": "20110801", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "354132", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130729", "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 A6.0P6", "catalog_number": "", "lot_number": "", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/08/2013;08/08/2013", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "N", "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": "20130729", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU", " DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "37 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20130627", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SUNNYVALE", "mdr_report_key": "3250944", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130627", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "10960648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON WAS NOT AVAILABLE; HOWEVER, A NURSE IN HIS OFFICE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE PATIENT UNDERWENT A ROUTINE DA VINCI MYOMECTOMY PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED DUE TO AN UNKNOWN REASON. THE PATIENT CODED AND RESUSCITATION OF THE PATIENT WAS ATTEMPTED WITHOUT SUCCESS. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THERE IS NO VIDEO RECORDING OF THE SURGICAL PROCEDURE AVAILABLE. THE PATIENT'S AUTOPSY REPORT IS CURRENTLY PENDING. THE NURSE WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE PATIENT'S DEMISE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOUND THAT THERE WERE NO SYSTEM ERRORS GENERATED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPIRED POST-OP A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "3663133", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI MYOMECTOMY PROCEDURE, WHILE UNDOCKING THE SYSTEM FROM THE PATIENT, THE PATIENT REQUIRED RESUSCITATION. THE ANESTHESIOLOGIST PERFORMED CHEST COMPRESSIONS ON THE PATIENT; HOWEVER, THE RESUSCITATION ATTEMPTS FAILED AND THE PATIENT EXPIRED." }, { "mdr_text_key": "191899514", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE HOSP. THE EVENT DETAILS ARE PROVIDED BELOW. A (B)(6) FEMALE UNDERGOING A ROBOTIC MYOMECTOMY AND BILATERAL NEOSALPINGOSTOMY HAD AN INTRAOPERATIVE DEATH. NEAR THE END OF THE PROCEDURE, THE PT'S BLOOD PRESSURE WAS NOT DETECTED IN THE PRESENCE OF A PULSE AND NORMAL OXYGENATION LEVELS. THE RHYTHM WAS NOTED TO BE PULSELESS ELECTRICAL ACTIVITY (PEA). DESPITE ACLS PROCEDURES AND AN ATTEMPT TO INSERT AN INTRA-AORTIC BALLOON PUMP TO SUSTAIN THE PT. ALL RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. RESUSCITATIVE EFFORTS WERE SUSTAINED OVER 2 HOURS. AT NO TIME WAS A PROBLEM WITH THE ROBOTIC EQUIPMENT REPORTED. THIS WAS AN UNEXPECTED DEATH." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1266 KIFER RD, BLDG 101", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/08/2013;09/09/2013" } ] }