{ "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": "2955842-2016-00175", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20160318", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160126", "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": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160318", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "166514", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160318", "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": [ "Leak/Splash" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20160318", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Bowel Perforation", "Death", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20160222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5510465", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160222", "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": "40676248", "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 ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH THE EVENT DATE OF (B)(6) 2016 WHICH WAS NOTED BY THE INITIAL REPORTER. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE INVOLVED WITH THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE INITIAL REPORTER, THE PATIENT UNDERWENT A DA VINCI-ASSISTED SURGICAL PROCEDURE, EXPERIENCED POST-OPERATIVE COMPLICATIONS, AND SUBSEQUENTLY PASSED AWAY A FEW DAYS LATER. HOWEVER, AT THIS TIME, THE CAUSES OF THE OPERATIVE COMPLICATIONS AND THE PATIENT'S SUBSEQUENT DEMISE ARE UNKNOWN. ALSO, ACCORDING TO THE SITE'S RISK MANAGER, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. REFER TO PATIENT IDENTIFIER (B)(6) FOR THE MDR SUBMISSION OF THE SECOND REPORTED OPERATIVE COMPLICATION AND PATIENT DEATH NOTED BY THE INITIAL REPORTER." }, { "mdr_text_key": "40676249", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5060196 WITH THE FOLLOWING EVENT DESCRIPTION: MY DAD WAS (B)(6), HE HAD TWO AREAS OF CANCER (COLON AND NEAR RECTUM) THAT HAD TO BE REMOVED BUT THEY WERE EARLY STAGES AND DID NOT REQUIRE CHEMO OR RADIATION. HE WAS HEALTHY AND STILL WORKED AS A SUPERVISOR FOR THE FEDERAL GOVERNMENT. HE WASN'T SICK AND HAD NO SYMPTOMS GOING INTO SURGERY. HE WASN'T TAKING ANY MEDS PRIOR TO SURGERY. ON (B)(6) 2016, HE HAD ROBOTIC SURGERY AT (B)(6) HOSPITAL IN (B)(6). SURGERY WAS SCHEDULED FOR 7 HRS, BUT TOOK 9 HRS. ON (B)(6) 2016, EMERGENCY SURGERY WAS PERFORMED TO REPAIR LEAKING ILEUM DUE TO NIPPED EQUIPMENT. BY THIS TIME, HIS ORGAN WERE HAVING PROBLEMS. ON (B)(6) 2016, ANOTHER EMERGENCY SURGERY. ON (B)(6) 2016, MY FATHER DIED. WHAT IS INTERESTING, I SENT A MASS EMAIL TO MY JOB REACHING OVER 100 PEOPLE TO EXPLAIN WHAT HAPPENED TO MY FATHER TO AVOID QUESTIONS. THERE WAS A CO-WORKER THAT LOST HER FATHER FROM ROBOTIC COLON SURGERY IN (B)(6) 2 YRS PRIOR. SHE EXPLAINED THE DOCTOR NIPPED AN AREA AND THEY HAD TO GO BACK INTO SURGERY TO FIX IT. HE LATER DIED; 7 DAYS LATER. PLEASE HELP US. THIS IS WRONG AND SO VERY SAD. MY FATHER'S LAST WORDS, THEY MESSED UP. IT'S HEARTBREAKING BECAUSE HE SUFFERED IN PAIN WHILE THE DOCTORS TRIED TO FIGURE IT OUT. OUR DOCTOR HAD 28 YEARS OF EXPERIENCE, BUT ONLY 1 YEAR EXPERIENCE OF ROBOTIC SURGERY. CONCOMITANT MEDICAL PRODUCTS: RX MEDS. HE WASN'T ON ANY MEDS OR USING ANY, MEDICAL DEVICES., OTC MEDS: HE DID TAKE MULTI-VITAMINS, BUT I'M, UNSURE WHAT BRAND. ON 02/23/2016, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED LIMITED INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER STATED THAT SHE IS NOT CLAIMING THAT THE ROBOTIC EQUIPMENT WAS FAULTY BUT BELIEVES THAT POSSIBLY THE LACK OF THE SURGEON'S EXPERIENCE WITH THE DA VINCI SURGICAL SYSTEM WAS A CONTRIBUTING FACTOR IN REGARDS TO THE OPERATIVE COMPLICATION THAT THE PATIENT (HER FATHER) EXPERIENCED. THE INITIAL REPORTER ALSO STATED THAT ONE OF HER CO-WORKERS MENTIONED ALSO THAT HER OWN FATHER UNDERWENT A ROBOTIC COLON PROCEDURE AT A DIFFERENT UNSPECIFIED HOSPITAL AND A SIMILAR EVENT HAPPENED WHERE THE PATIENT EXPERIENCED A LEAK AND PASSED AWAY. THE INITIAL REPORTER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. ON 03/15/2016, ISI CONTACTED THE SITE'S RISK MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED COLON RESECTION PROCEDURE THAT THE PATIENT INITIALLY UNDERWENT ON (B)(6) 2016. THE RISK MANAGER CONFIRMED THAT THE PATIENT EXPERIENCED A LEAKING ILEUM BUT SHE COULD NOT PROVIDE A POSSIBLE CAUSE FOR THE OPERATIVE COMPLICATION. SHE ALSO COULD NOT CLARIFY THE INITIAL REPORTER'S STATEMENT THAT THE LEAKING ILEUM WAS DUE TO NIPPED EQUIPMENT. THE RISK MANAGER INDICATED THAT SHE HAS NOT YET RECEIVED THE AUTOPSY REPORT AND THEREFORE DOES NOT KNOW WHAT THE PATIENT'S CAUSE OF DEATH IS. THE RISK MANAGER CONFIRMED THAT THE PATIENT PASSED AWAY A FEW DAYS AFTER UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE ACTUAL DATE OF THE PATIENT'S DEATH WAS NOT PROVIDED. SHE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED 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": "" } ] }