{ "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": "2955842-2014-04974", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140815", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110218", "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": "20140815", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "491219", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140815", "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 A5.1P8", "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": "20250815", "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": "20140815", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Death", "Low Blood Pressure/ Hypotension", "Necrosis", "Sepsis", "Strangulation", "Ulceration", "Vomiting", "Hernia", "Respiratory Failure", "Abdominal Distention", "Bowel Perforation", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20140716", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4012746", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140716", "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": "4688160", "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 ROBOTIC PROCEDURE - SMALL BOWEL RESECTION FOR FOREIGN BODY (CAMERA) OF SMALL BOWEL, POSSIBLE INFLAMMATORY MASS ON (B)(6) 2011. PER THE MEDICAL RECORDS, THE PATIENT HAD PERSISTENT ANEMIA, HAD HAD NEGATIVE WORKUP, AND THEN UNDERWENT INGESTION OF A VIDEOCAMERA IN (B)(6) 2009, BUT WAS UNABLE TO PASS THE CAMERA. AFTER SEVERAL ATTEMPTS AT THIS, SHE ELECTED TO HAVE OPERATIVE INTERVENTION. ADDITIONAL RECORDS STATE THAT THE PATIENT WAS UNABLE TO PASS THE CAPSULE AND WAS FOUND TO HAVE A SMALL AREA OF ULCERATION AND FIBROSIS. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE MULTIPLE AREAS OF THICKENED MESENTERY. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, NEAR THE ILEOJEJUNAL JUNCTION, THERE WAS AN AREA OF SMALL BOWEL THAT HAD THICKENED MESENTERY AND FELT 2 OR 3 AREAS OF NARROWING THAT WOULD CAUSE THE CAMERA TO GET CAUGHT IN THIS SPACE. THE ROBOT WAS THEN BROUGHT INTO THE FIELD AND DOCKED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. AFTER THE DA VINCI SURGERY, THE PATIENT PRESENTED WITH THE FOLLOWING: ABDOMINAL PAIN, BOWEL LEAK, SEPSIS, AND SUBSEQUENT DEATH. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF VOMITING AND ABDOMINAL PAIN. PER THE HISTORY AND PHYSICAL, SINCE SURGERY, THE PATIENT HAS HAD DECREASED APPETITE. SHE WAS DISCHARGED HOME 2 DAYS AGO AND STATES THAT THERE HAS BEEN ONLY 1 DAY THAT SHE HAS NOT VOMITED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND DEVELOPED ABDOMINAL DISTENTION LAST NIGHT AND DECIDED TO COME TO THE EMERGENCY ROOM. SHE WAS NOTED TO BE HYPOTENSIVE AND HAVE LOW IONIZED CALCIUM. CT WAS PERFORMED WHICH SHOWED SMALL BOWEL PERFORATION MOST LIKELY HAD SUTURE LINE LEAK. ON (B)(6) 2011, THE PATIENT UNDERWENT INSERTION OF A CENTRAL LINE, SMALL BOWEL RESECTION X2, AND GASTROTOMY FOR PERFORATED SMALL BOWEL PROXIMAL TO THE STAPLE LINE SECONDARY TO HERNIATION THROUGH MESENTERIC DEFECT. THE OPERATIVE REPORT STATES, THE STAPLE LINE WAS OBSERVED. IT WAS INTACT. HOWEVER, THE MESENTERIC DEFECT BELOW THE STAPLE LINE, WHICH HAD BEEN SUTURED WITH SILK HAD PULLED THROUGH AT THE BOTTOM AND SMALL BOWEL HERNIATED THROUGH THIS PRODUCING SOME NECROSIS WITH PERFORATION. UPON INSPECTION, THE SMALL BOWEL AT THE AREA OF SUTURE LINE SEEMS TO BE SOMEWHAT CYANOTIC. ON (B)(6) 2011, THE PATIENT PASSED AWAY. THE DISCHARGE SUMMARY STATES, CT PERFORMED SHOWED A LEAK AND SHE WAS TAKEN TO THE OPERATING ROOM. SHE WAS FOUND TO HAVE A SMALL BOWEL HERNIATION AND STRANGULATION. SHE UNDERWENT A SMALL BOWEL RESECTION. THE PATIENT DID HAVE RESPIRATORY FAILURE REQUIRING VENTILATOR SUPPORT. SHE IS ALSO REQUIRING PRESSOR SUPPORT. SHE WAS PLACED ON BROAD-SPECTRUM IV ANTIBIOTICS AND PRESSORS; HOWEVER, SHE CONTINUED TO DETERIORATE. THE PROGNOSIS WAS DISCUSSED WITH THE PATIENT'S FAMILY, AND THEY REQUESTED COMFORT CARE ONLY. THE NEXT MORNING, THE PATIENT'S FAMILY REQUESTED COMFORT CARE. SHE CONTINUED TO DETERIORATE AND EXPIRED AT 5:45 PM. SHE WAS NOT RESUSCITATED PER HER FAMILY'S REQUEST. ACCORDING TO THE PATIENT'S DEATH CERTIFICATE, THE CAUSE OF THE PATIENT'S DEATH WAS SEPSIS DUE TO OR AS A CONSEQUENCE OF A PERFORATED VISCUS." }, { "mdr_text_key": "11985905", "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 FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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 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": "" } ] }