{ "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": "Death", "report_number": "2955842-2016-00198", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20160325", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20160223", "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", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160325", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "182319", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160325", "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, A51P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20160325", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Inflammation", "Perforation", "Septic Shock", "Injury", "Death", "Inflammation", "Perforation", "Septic Shock", "Injury" ] } ], "distributor_city": "", "date_report": "20160225", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5526664", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160225", "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": "41181634", "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 OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. 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) 2016 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT WAS FOUND TO HAVE SUSTAINED A SMALL BOWEL ENTEROTOMY, DEVELOPED AN INFECTION, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT IS UNKNOWN." }, { "mdr_text_key": "41181635", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016, IT WAS INITIALLY REPORTED BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2016, THE PATIENT WAS IN A BAD GENERAL STATE AND WAS TRANSFERRED TO EMERGENCY SERVICE. A SURGEON REPORTEDLY FOUND A LITTLE WOUND ON THE SMALL INTESTINE AT UNSPECIFIED TIME AFTER THE DA VINCI PROCEDURE WAS COMPLETED. THE PATIENT WAS NOTED TO BE IN THE ICU. ON 02/29/2016 AND 03/03/2016, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CSR AND THE ISI AREA SALES MANAGER (ASM). THE CSR WAS PRESENT DURING THE CASE AND THE INFORMATION SOURCE IS BASED ON THE CSR'S OBSERVATION AND DISCUSSIONS WITH THE PROCTOR: PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT HAD MULTIPLE, PREVIOUS ABDOMINAL SURGERIES AND COMPLICATIONS IN THE PAST INCLUDING A PARTIAL NEPHRECTOMY, CHOLECYSTECTOMY, BILE DUCT INFLAMMATION (CHOLEDOCH), AND A PERFORATION OF ANOTHER UNSPECIFIED STRUCTURE. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF HAD DIFFICULTIES WITH PLACING THE TROCAR(S) DUE TO HERNIA MESHES PLACED IN THE ABDOMINAL WALL DURING PREVIOUSLY UNDERGONE SURGERIES. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS NOT COMPLETED AS IT WAS TOO DIFFICULT FOR THE SURGICAL STAFF TO IDENTIFY TARGET ANATOMY AND AFTER AN HOUR, THE SURGEON MADE THE DECISION TO STOP AND TO DISCUSS ALTERNATIVE TREATMENT WITH THE PATIENT SUCH AS OPEN SURGERY OR RADIOLOGICAL TREATMENT. DURING THE EVENING, THE PATIENT DEVELOPED A FEVER AND A SMALL HOLE WAS FOUND ON THE PATIENT'S BOWEL DURING A SECOND UNSPECIFIED OPEN SURGICAL PROCEDURE PERFORMED THE FOLLOWING DAY. THE CAUSE OF THE SMALL BOWEL ENTEROTOMY IS NOT KNOWN. IN THE PROCTOR'S OPINION, THE DIFFICULT ANATOMY, COMPLEX SURGERY, AND MEDICAL HISTORY (HERNIA MESH) WERE CONTRIBUTING FACTORS TO THE CAUSE OF THE PATIENT'S DEATH. IT IS UNKNOWN IF AN AUTOPSY HAS BEEN PERFORMED; HOWEVER, THE PROCTOR INDICATED THAT THE PATIENT PASSED AWAY DUE TO SEPTIC SHOCK RELATED TO THE SMALL BOWEL ENTEROTOMY. ACCORDING TO THE PROCTOR, THE PATIENT MAY NOT HAVE BEEN SUITABLE FOR A DA VINCI-ASSISTED SURGICAL PROCEDURE. PER THE PROCTOR, NOTHING SPECIAL OCCURRED DURING SURGERY AND THERE WAS NO OBVIOUS HUMAN ERROR." }, { "mdr_text_key": "45611985", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 04/22/2016, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ACCORDING TO THE ISI CLINICAL SALES REPRESENTATIVE (CSR), THE ROOT CAUSE OF THE BOWEL INJURY HAS STILL NOT BEEN DETERMINED. THE CSR INDICATED THAT THE OFFICIAL CAUSE OF DEATH IS SEPTIC SHOCK. HOWEVER, THE OFFICIAL DATE OF THE PATIENT'S DEATH HAS NOT BEEN CONFIRMED. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT WAS FOUND TO HAVE SUSTAINED A SMALL BOWEL ENTEROTOMY, DEVELOPED AN INFECTION, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT IS UNKNOWN." } ], "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": "05/20/2016" } ] }