{ "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": "2955842-2012-00146", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120406", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120801", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120406", "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 A60.P5", "catalog_number": "", "lot_number": "", "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": "", "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": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20120406", "sequence_number_treatment": [ "DA VINCI SI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Septic Shock" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2521982", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120309", "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": "2530642", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 2 DAYS POST-OP A DA VINCI SI GASTRIC BYPASS PROCEDURE, THE PATIENT DEVELOPED SEPTIC SHOCK AFTER THE JEJUNUM (JJ) AND GASTROJEJUNUM (GJ) STAPLE LINES AND SUTURE CLOSURES OPENED. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES AND IT IS THE SURGEON'S BELIEF THAT OPENING OF THE JJ AND GS STAPLE LINES AND SUTURE CLOSURES WAS RELATED TO THE PATIENT'S ANATOMY. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "9896351", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON APRIL 4, 2012 THE INTUITIVE SURGICAL CONTACTED (B)(6) HOSPITAL'S RISK MANAGER AND THE RISK MANAGER INDICATED THAT SHE IS UNABLE TO PROVIDE ANY INFORMATION CONCERNING THE REPORTED EVENT WITHOUT A PATIENT NAME AND/OR DATE OF THE SURGICAL PROCEDURE. TO DATE, NO INFORMATION HAS BEEN RECEIVED WHICH SUGGESTS THAT THE DA VINCI SI SURGICAL SYSTEM MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POST SURGICAL COMPLICATIONS. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "16625045", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CORRECTED INFORMATION CAN BE FOUND IN SECTION TYPE OF REPORTABLE EVENT. INITIAL MDR WAS INADVERTENTLY SENT WITH INCORRECT INFORMATION IN TYPE OF REPORTABLE EVENT." } ], "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": "01/10/2013" } ] }