{ "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": "2955842-2014-05743", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141126", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130325", "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": "20141126", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "767835", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141126", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20141126", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "63", "patient_sex": "", "patient_weight": "103", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Adhesion(s)", "Death", "Fistula", "Low Blood Pressure/ Hypotension", "Inflammation", "Ischemia", "Nausea", "Necrosis", "Sepsis", "Tachycardia", "Urinary Retention", "Vomiting", "Obstruction/Occlusion", "Abdominal Distention", "Constipation" ] } ], "distributor_city": "", "date_report": "20141031", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4280830", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141031", "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": "16303634", "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 WHO UNDERWENT A DA VINCI ASSISTED ELECTIVE SIGMOID COLECTOMY PROCEDURE FOR RECURRENT ACUTE DIVERTICULITIS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND PATIENT'S MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT HAD 2 WELL DOCUMENTED EPISODES OF ACUTE DIVERTICULITIS. ONE EPISODE INVOLVED A SMALL PERICOLIC ABSCESS. DURING THE SURGICAL PROCEDURE, ADHESIONS WERE NOTED. NO COMPLICATIONS WERE REPORTED. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. POST-OPERATIVELY, THE PATIENT DEVELOPED URINARY RETENTION WHICH WAS RESOLVED BY DISCHARGE. THE PATIENT WAS ABLE TO TOLERATE A REGULAR DIABETIC DIET. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED ON ORAL PAIN MEDICATION. ON (B)(6) 2013, A CT-SCAN WAS PERFORMED FOR CONSTIPATION AND THE PATIENT WAS FOUND TO HAVE A SMALL BOWEL OBSTRUCTION AND A PRIOR COLON RESECTION WITH ANASTOMOTIC SITE NOTED AT THE RECTOSIGMOID JUNCTION. POST-SURGICAL CHANGES VERSUS RESIDUAL INFLAMMATORY CHANGES WERE ALSO OBSERVED IN THE LEFT LOWER QUADRANT. ALSO, SMALL FREE FLUID WAS OBSERVED IN THE LEFT PARACOLIC GUTTER. ON 04/02/2013, THE PATIENT WAS ADMITTED FOR DELAYED POST-OP ILEUS. THE PATIENT WAS NOTED TO HAVE ABDOMINAL DISTENTION, NAUSEA AND VOMITING FOR THE PREVIOUS 24 HOURS. THE PATIENT'S WHITE BLOOD CELL COUNT WAS 22,000. HE WAS PLACED ON BOWEL REST AND IV FLUIDS. THE PATIENT WAS THEN NOTED TO BE AFEBRILE AND HIS WHITE COUNT RETURNED TO NORMAL. ON (B)(6) 2013, A GASTROGRAFIN ENEMA SHOWED AN ANASTOMOTIC LEAK WITH A SUSPECTED FISTULA TO THE SMALL BOWEL. DURING THE POST-ENEMA PERIOD, THE PATIENT DEVELOPED SYMPTOMS OF HYPOTENSION, TACHYPNEA, AND TACHYCARDIA WITH A DIFFUSELY DISTENDED ABDOMEN CONSISTENT WITH ACUTE SURGICAL ABDOMEN. THAT SAME DAY, AN ABDOMINAL X-RAY FOR HYPOXIA REVEALED DILATED LOOPS OF SMALL BOWEL IN THE MID-ABDOMEN AND RIGHT LOWER QUADRANT. CONTRAST WAS NOTED IN THE LEFT COLON AND RIGHT COLON. AN EMERGENT EXPLORATORY LAPAROTOMY REVEALED THE PATIENT'S SMALL BOWEL BEING VERY DUSKY. GENERALIZED ISCHEMIA WITH ISCHEMIC AREAS OF SMALL BOWEL AND COLON WERE OBSERVED. THE PATIENT WAS NOTED TO HAVE DEVELOPED AN ANASTOMOTIC DEHISCENCE. ISCHEMIC NECROSIS OF ESSENTIALLY THE ENTIRE DESCENDING COLON WAS OBSERVED. THE PATIENT UNDERWENT TAKEDOWN OF THE ANASTOMOSIS, A PARTIAL LEFT COLECTOMY, AND CREATION OF A DIVERTING LOOP ILEOSTOMY. THE SMALL BOWEL PINKED UP AND BECAME LESS DUSKY. HOWEVER, THE SURGEON EXPRESSED CONCERN FOR VIABILITY OF THE ENTIRE GI TRACT DUE TO THE PATIENT'S HISTORY OF VASCULAR DISEASE AND FINDINGS UPON ENTERING THE ABDOMINAL CAVITY. THE PATIENT WAS THEN TRANSFERRED TO THE ICU IN CRITICAL CONDITION. POST-OPERATIVELY, THE PATIENT EXPERIENCED HYPOTENSIVE SHOCK AND MEDICATIONS WERE ADMINISTERED. THE PATIENT ALSO EXPERIENCED ACUTE RESPIRATORY FAILURE. HE WAS INTUBATED ON A VENT AND SEDATED. ON (B)(6) 2013, THE PATIENT EXPERIENCED OLIGURIC ACUTE RENAL FAILURE. THAT SAME DAY, THE PATIENT UNDERWENT LEFT INTERNAL JUGULAR LINE PLACEMENT FOR DIALYSIS. ON (B)(6) 2013, THE INFECTIOUS DISEASE DEPARTMENT WAS CONSULTED. THE PATIENT WAS NOTED TO HAVE SEVERE SEPSIS WITH WORSENING LEUKOCYTOSIS. THE PATIENT WAS CONTINUED ON MEDICATIONS. ON (B)(6) 2013, THE PATIENT WAS OFF SEDATION FOR MORE THAN 24 HOURS AND REMAINED COMATOSE. AN EEG WAS FOUND TO BE ABNORMAL DUE TO PRESENCE OF CONTINUOUS SEVERE GENERALIZED SLOWING CONSISTENT WITH SEVERE DIFFUSE CEREBRAL DYSFUNCTION. THE PATIENT HAD PROGRESSIVE SLOW DETERIORATION WITH EVENTUAL DEATH ON (B)(6) 2013. A PHYSICIAN NOTED THE PATIENT'S DEATH WAS PROBABLY SECONDARY TO OVERWHELMING SEPSIS." }, { "mdr_text_key": "16385645", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. DURING THE SURGICAL PROCEDURE, SEVERAL SYSTEM ERROR CODE 32003'S WERE GENERATED. AN ERROR CODE 32003 SIGNIFIES THAT THE VESSEL SEALER INSTRUMENT WAS NOT ABLE TO DRIVE THE CUTTING BLADE ACROSS THE FULL RANGE OF TRAVEL DURING A CUT COMMAND. THIS CAN BE CAUSED BY A DIRTY VESSEL SEALER INSTRUMENT OR IF THE USER ATTEMPTS TO CUT VERY THICK AND/OR UNSEALED TISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERWENT A DA VINCI SURGICAL PROCEDURE SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE 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": "" } ] }