{ "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": "2955842-2016-00020", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20160108", "manufacturer_address_2": "", "pma_pmn_number": "K063221", "date_of_event": "20151202", "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 REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160108", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "12967", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160108", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "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": "20160108", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiopulmonary Arrest", "Cardiopulmonary Arrest" ] } ], "distributor_city": "", "date_report": "20151209", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5354512", "removal_correction_number": "", "number_devices_in_event": "", "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": "35460642", "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 COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO SYSTEM ERRORS OCCURRED IN RELATION TO THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ON POST-OPERATIVE DAY 7, A PORTION OF THE PATIENT'S SMALL BOWEL HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES AND THE PATIENT REPORTEDLY CODED. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE HERNIATION AND THE REASON WHY THE PATIENT CODED IS UNKNOWN. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION." }, { "mdr_text_key": "35460643", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT'S SMALL BOWEL HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES ON POST-OPERATIVE DAY 7. ON (B)(6) 2015 AND (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. AFTER THE ROBOTIC PORTION OF THE CASE WAS COMPLETED, THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY TO FINISH AN ANASTOMOSIS. THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2015, THE PATIENT'S SMALL BOWEL WAS FOUND TO HAVE HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO REPAIR THE HERNIATION. THAT SAME DAY ON (B)(6) 2015, THE PATIENT REPORTEDLY CODED. THE INITIAL REPORTER DID NOT KNOW THE REASON AS TO WHY THE PATIENT CODED. THE INITIAL REPORTER STATED THAT THE SURGEON DOES NOT CLOSE ANY ROBOTIC PORT SITES THAT ARE LESS THAN 10MM. ON (B)(6) 2015, THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS STILL IN THE HOSPITAL AND HAD BEEN INTUBATED. ON (B)(6) 2016, THE INITIAL REPORTER DID NOT HAVE ANY UPDATES REGARDING THE PATIENT'S CURRENT STATUS." } ], "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": "" } ] }