{ "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": "2955842-2015-00942", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150626", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121227", "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": "20150626", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "416232", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150626", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20150626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "54", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Death", "Diarrhea", "Edema", "Cardiac Enzyme Elevation", "Low Blood Pressure/ Hypotension", "Inflammation", "Myocardial Infarction", "Pain", "Sepsis", "Septic Shock", "Weakness", "Peritonitis", "Complaint, Ill-Defined", "Respiratory Failure", "Lethargy", "Abdominal Distention", "Bowel Perforation", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "date_report": "20150529", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4871260", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150529", "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": "13303775", "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 COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. 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) 2012. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE IS UNKNOWN." }, { "mdr_text_key": "5860253", "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-ASSISTED ALLOGRAFT COLPOPEXY, CYSTOCELE REPAIR, TVT MID URETHRAL TAPE WITH CYSTOSCOPY FOR TOTAL VAGINAL PROLAPSE WITH SEVERE CYSTOCELE, RECTOCELE AND ENTEROCELE AND URINARY INCONTINENCE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. PER THE OPERATIVE REPORT, SURGICAL FINDINGS INCLUDED SIGNIFICANT ADHESIONS OF LOOPS OF SMALL BOWEL TO THE PELVIS, CUL-DE-SAC IN THE MIDLINE, AND RIGHT SIDE WALL. THE SURGEON PERFORMED THE LYSIS OF ADHESIONS ROBOTICALLY AND THE SACRAL COLPOPEXY AND TVT PORTIONS OF THE SURGERY. ANOTHER SURGEON PERFORMED THE RECTOCELE AND ENTEROCELE REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, PER A UROGYNECOLOGY OFFICE NOTE, THE FOLLOWING WAS NOTED, FEELING SORE IN ABD, REPORTED 'PURPLE LINES' NO EVIDENCE OF INFECTION, AND NO ANTIBIOTICS. IN ADDITION, THE PATIENT WAS USING IBUPROFEN FOR PAIN. THERE WAS NO OXYCODONE USE. THE PATIENT WAS VOIDING WELL WITH NO FREQUENCY OR UI (POSSIBLY URINARY INFECTION) AND NO VAGINAL BLEEDING. THE PATIENT HAD LIGHT DISCHARGE. ON (B)(6) 2013, THE PATIENT PRESENTED TO AN ER WITH COMPLAINTS OF INCREASED ABDOMINAL PAIN, DISTENTION, AND INTERMITTENT DIARRHEA FOR THREE DAYS. THE PATIENT INDICATED THAT HER ABDOMEN WAS LARGER THAN NORMAL SINCE THE SURGERY. THE PATIENT'S HUSBAND REPORTED THAT SHE WAS VERY WEAK AND LETHARGIC ALL DAY. THE PATIENT WAS NOTED TO HAVE A HARD ABDOMEN WITH DIMINISHED BOWEL SOUNDS, SEVERE DISTENTION, TYMPANITIC, AND MODERATE TENDERNESS. THE PATIENT WAS HYPOTENSIVE, AND WBCS AND LIVER ENZYMES WERE ELEVATED. ON (B)(6) 2013, AN ABDOMINAL CT-SCAN SHOWED FLUID THROUGH THE ABDOMEN WITH LOCULATED FLUID COLLECTIONS IN THE PELVIS. THICKENING OF THE COLON WITH PNEUMATOSIS WAS NOTED. CONCERN FOR A BOWEL INJURY OR PERFORATION AND COLITIS WAS NOTED. THE IMPRESSION INCLUDED ACUTE ABDOMEN PERITONITIS WITH PROBABLE PERFORATED VISCUS OR TOXIC COLITIS. THAT SAME DAY, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION OF THE ILEUM WITH PRIMARY ANASTOMOSIS, AND RESECTION OF THE JEJUNUM WITH END LOOP JEJUNOSTOMY. SURGICAL FINDINGS INCLUDED AN ILEAL PERFORATION AND MULTIPLE INTRA-ABDOMINAL ADHESIONS. COPIOUS AMOUNTS OF ENTERIC CONTENTS THROUGHOUT THE ENTIRE PELVIS AND MIDABDOMEN WERE NOTED. THREE SEPARATE ENTEROTOMIES WERE CREATED DURING DISSECTION AND ALL WERE RESECTED. POSTOPERATIVELY, THE PATIENT HAD SEVERE HYPOTENSION AND WAS MAXED OUT ON VASOPRESSORS. SHE WAS NOTED TO BE AWAKE AND RESPONSIVE. THE PATIENT REMAINED ON MECHANICAL VENTILATION. ON (B)(6) 2013, THE PATIENT REMAINED CRITICALLY ILL AND ON A VENTILATOR. THE PATIENT'S SYSTOLIC BLOOD PRESSURE REMAINED IN THE 50S ON MAXIMUM DOSAGE OF VASOPRESSORS. THE PATIENT WAS IN TRENDELENBURG POSITION, TACHYPNEIC AND RECEIVING AGGRESSIVE FLUID RESUSCITATION. THE IMPRESSION INCLUDED A PERFORATED VISCUS WITH SEVERE PERITONITIS; SEPTIC SHOCK; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; METABOLIC ACIDOSIS; AND ACUTE RESPIRATORY FAILURE. THE PATIENT WAS ALSO ANURIC WITH NO URINE OUTPUT FOR A 12 HOUR TIME PERIOD. EKG CHANGES WERE NOTED AND CONSISTENT WITH A MYOCARDIAL INFARCTION. CARDIAC ENZYMES WERE ELEVATED AND POSITIVE FOR ACUTE MYOCARDIAL INFARCTION. LABORATORY RESULTS AND CLINICAL COURSE SUGGESTED MULTISYSTEM ORGAN FAILURE. THE PATIENT REMAINED ON MAXIMUM PRESSOR MEDICATIONS. HER CONDITION CONTINUED TO DETERIORATE AND SHE EXPIRED ON (B)(6) 2013 AT 11:42 PM. THE PATIENT'S FINAL DIAGNOSIS WAS SMALL BOWEL PERFORATION WITH SECONDARY DIAGNOSES OF MYOCARDIAL INFARCTION, SYSTEMIC INFLAMMATORY RESPONSE SYSTEM, SEPSIS, AND MULTISYSTEM ORGAN FAILURE. ACCORDING TO THE PATHOLOGY REPORT, THREE SECTIONS OF SMALL INTESTINE WERE SUBMITTED FOR ANALYSIS ON (B)(4) 2013. ONE SEGMENT WAS EXTENSIVELY RED AND CONGESTED WITH ADHESIONS. TWO TRANSMURAL DEFECTS WERE NOTED. ONE SEGMENT WAS ALSO NOTED TO BE CONGESTED WITH ADHESIONS AND WITH AN IRREGULAR TRANSMURAL DEFECT. OF THE SPECIMENS SUBMITTED, TWO PERFORATIONS IN THE LARGER SEGMENT AND ONE PERFORATION IN THE MEDIUM-SIZED SPECIMEN DEMONSTRATED MARKED FIBRINOPURULENT SEROSITIS AND ASSOCIATED FOREIGN-BODY GIANT CELL REACTION WITHIN THE SUBSEROSA. THE BOWEL MUCOSA DISPLAYED VARIABLE DEGREES OF ACUTE INFLAMMATION WITH CRYPT ATROPHY, SURFACE EROSIONS, AND ISCHEMIC-TYPE CHANGES. SUBMUCOSAL EDEMA AND VASCULAR CONGESTION WERE PROMINENT. AREAS WERE SUGGESTIVE OF PNEUMATOSIS. THE SMALLEST INTESTINAL SEGMENT SHOWED MILD MUCOSAL ACUTE INFLAMMATION, SUBMUCOSAL EDEMA, AND FIBRINOPURULENT SEROSITIS." } ], "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": "" } ] }