{ "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": "2955842-2014-01029", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140220", "manufacturer_address_2": "", "pma_pmn_number": "K021036", "date_of_event": "20060324", "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": "20140221", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "107718", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140220", "brand_name": "DA VINCI 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": "IS1200", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20140220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20140124", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3638248", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140124", "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": "20486860", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE ." }, { "mdr_text_key": "20104003", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI DIAGNOSTIC LAPAROSCOPY AND CHOLECYSTECTOMY PROCEDURE FOLLOWED BY A PLANNED OPEN PANCREATICODUODENECTOMY SURGICAL PROCEDURE ON (B)(6) 2006. THE PATIENT REPORTEDLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE (B)(6) 2006 OPERATIVE REPORT AS WELL AS HER SUBSEQUENT OPERATIVE SUMMARIES AND HER HOSPITAL DISCHARGE SUMMARY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER CARE ON (B)(6) 2006 AND THEN WAS DISCHARGED ON (B)(6) 2006. NO FURTHER MEDICAL RECORDS WERE PROVIDED AFTER THIS DISCHARGE DATE. THE OPERATIVE REPORT DATED (B)(6) 2006 INDICATED THAT THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPY AND CHOLECYSTECTOMY, OPEN PANCREATICODUODENECTOMY, PORTAL VEIN RESECTION AND RECONSTRUCTION. THE PREOPERATIVE DIAGNOSIS WAS NOTED AS PANCREATIC HEAD MASS AND CYSTIC NEOPLASM AND THE POSTOPERATIVE DIAGNOSIS WAS PANCREATIC CARCINOMA. THE SURGICAL PROCEDURE BEGAN WITH A ROBOTIC ASSISTED DIAGNOSTIC LAPAROSCOPY TO IDENTIFY THE BODY AND NECK OF THE PANCREAS. THE PROCEDURE THEN PROCEEDED WITH A CHOLECYSTECTOMY. ONCE THE COMMON BILE DUCT AND PROXIMAL PORTAL VEIN WAS DISSECTED, THE DA VINCI SYSTEM WAS UNDOCKED. THE SURGERY WAS THEN CONVERTED TO OPEN AS PLANNED ACCORDING TO THE SURGEON. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY IN THE DURING THE ROBOTIC ASSISTED PORTION OF THE SURGERY. THE OPEN OPERATION WAS A COMPLEX PANCREATIC AND DUODENAL RESECTION WHERE THE PORTAL VEIN HAD TO BE EXCISED AND RECONSTRUCTED DUE TO INVASION BY A CANCEROUS TUMOR. THE PATIENT LOST APPROXIMATELY 2,000 ML OF BLOOD AND NO INTRA-SURGICAL COMPLICATIONS WERE NOTED. ACCORDING TO THE ADDITIONAL MEDICAL RECORDS, THE PATIENT'S HOSPITAL COURSE INCLUDED SEVERAL ADVERSE COMPLICATIONS, INCLUDING 3 SUBSEQUENT LAPAROTOMIES . ON (B)(6) 2006, THE PATIENT UNDERWENT A PLANNED RE-EXPLORATION FOR CLOSURE OF FASCIA AND PLACEMENT OF FEEDING JEJUNOSTOMY. ON (B)(6) 2006, THE PATIENT UNDERWENT AN URGENT EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION, ENTEROENTEROSTOMY, MESH FOR VENTRAL HERNIA REPAIR, JACKSON-PRATT PLACEMENT X2 FOR GANGRENOUS NECROTIC SMALL BOWEL LEAK FROM JEJUNOJEJUNOSTOMY SITE. ON (B)(6) 2006, ANOTHER EXPLORATORY LAPAROTOMY WAS PERFORMED WITH FINDINGS OF SMALL LEAK AT OLD JEJUNOCECOSTOMY SITE. THE PATIENT WAS DISCHARGED FROM THE INITIAL HOSPITALIZATION ON (B)(6) 2006. SHE WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER FACILITY FOR FURTHER RECOVERY AND NUTRITIONAL SUPPORT SOMETIME IN (B)(6) 2006, THE PATIENT HAD COMPLICATIONS RELATED TO EDEMA AND FISTULA AND WAS EVENTUALLY DISCHARGED ON (B)(6) 2006 IN STABLE CONDITION. NO OTHER MEDICAL RECORDS WERE PROVIDED FOR EVENTS THAT OCCURRED AFTER THE PATIENT'S HOSPITAL DISCHARGE ON (B)(6) 2006. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S DEMISE, SUCH AS THE CAUSE OF DEATH AND DATE OF DEATH." } ], "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": "" } ] }