{ "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": "N", "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": "", "event_type": "Injury", "report_number": "2955842-2012-00114", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120312", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94086", "reporter_occupation_code": "HEALTH PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "REED", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94086", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120313", "manufacturer_contact_f_name": "TABITHA", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120312", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/15/2013", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "health_professional": "Y", "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": "20120312", "sequence_number_treatment": [ "DA VINCI SURG SYSTEM, INSTRUMENT AND ACCESSORIES.", " NA.", " DA VINCI SURG SYSTEM, INSTRUMENT AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "1 MO", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Complaint, Ill-Defined", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20120211", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SUNNYVALE", "mdr_report_key": "2488683", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120211", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94086", "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": "2550956", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI GALL BLADDER PROCEDURE WAS FOUND POSTED ON THE (B)(6) BY INTUITIVE SURGICAL ON (B)(6) 2012: (B)(6), MY SON WAS ALMOST KILLED AFTER A SURGEON USED THE DA VINCI MACHINE TO REMOVE HIS GALL BLADDER. NO OTHER DETAILS WERE PROVIDED. ISI WAS UNABLE TO CONTACT THE AUTHOR OF THE POST CONCERNING THE REPORTED EVENT, AS THE AUTHOR HAS BLOCKED THEIR (B)(6) ACCOUNT." }, { "mdr_text_key": "9675129", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON MARCH 4, 2012, THE AUTHOR OF THE PATIENT STORY ORIGINALLY POSTED ON (B)(6) 2012, POSTED THE FOLLOWING ADDITIONAL INFORMATION: (B)(6): MY SON HAD SURGERY ON HIS GALL BLADDER, THE DA VINCI MACHINE WAS RECOMMENDED WE WERE TOLD IT WOULD BE LESS INVASIVE AND SHORTER RECOVERY TIME THAT WAS A BIG MISTAKE, HE ALMOST DIED. THEY CUT A SMALL HOLE IN HIS INTESTINE, ON THE THIRD DAY, HE LOOKED LIKE A (B)(6) VICTIM. HE WAS SENT HOME I THEN TOOK HIM TO ANOTHER HOSPITAL. HE HAS HAD 3 MORE SURGERIES AND NEEDS MORE. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER CONCERNING THE REPORTED EVENT. HOWEVER, NO RESPONSE HAS BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1266 KIFER RD, BLDG 101", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94086", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/15/2013" } ] }