{ "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": "I", "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": "2955842-2017-00582", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20170831", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20150810", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20170831", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "615346", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170831", "brand_name": "DA VINCI XI 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": "IS4000 A70P6B", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/03/2017", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20170831", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Septic Shock", "Bowel Perforation", "Death", "Septic Shock", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20170811", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6835014", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170811", "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": "84252504", "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 OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR 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) 2015. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A BOWEL PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, DEVELOPED MULTIPLE POST-OPERATIVE COMPLICATIONS, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS AND DEATH ARE UNKNOWN." }, { "mdr_text_key": "84252505", "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 PARACOLOSTOMY HERNIA REPAIR PROCEDURE ON (B)(6) 2015. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED A PERFORATED SMALL BOWEL DURING THE SURGICAL PROCEDURE THAT WENT UNTREATED FOR SEVERAL DAYS BEFORE HIS DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, THE SURGEON ENCOUNTERED MULTIPLE MASSIVE ADHESIONS DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED EXCRUCIATING ABDOMINAL PAIN THAT BEGAN THE EVENING THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS ADMINISTERED MULTIPLE UNSPECIFIED PAIN MEDICATIONS. POST-OPERATIVELY, THE PLAINTIFF'S ATTORNEY NOTED THAT THE PATIENT DEVELOPED CLINICAL AND LABORATORY SIGNS COMMONLY REFERRED TO AS RED FLAGS THAT WERE CONSISTENT WITH PERITONITIS, SEPSIS AND SEPTIC SHOCK, INCLUDING WITHOUT LIMITATION, ABDOMINAL PAIN, ABDOMINAL TENDERNESS, INCREASED WHITE BLOOD COUNT WITH BANDEMIA, PROGRESSIVE TACHYCARDIA, PROGRESSIVE HYPOXMIA, INCREASED RESPIRATORY RATE, RESPIRATORY FAILURE, DEHYDRATION, ACUTE RENAL FAILURE, AND ULTIMATELY CARDIOVASCULAR COLLAPSE. BASED ON A CT STUDY PERFORMED ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH A PERFORATED SMALL BOWEL. THAT SAME DAY, THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE TO STITCH INFLAMED TISSUE NEAR THE SMALL BOWEL PERFORATION. THE FOLLOWING DAY, (B)(6) 2015, THE PATIENT REPORTEDLY EXPIRED FROM A PERFORATED SMALL BOWEL, SEPTIC SHOCK, AND MULTISYSTEM ORGAN FAILURE." }, { "mdr_text_key": "105828958", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT ON (B)(6) 2017: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, NO ENTEROTOMIES WERE OBSERVED. THE SURGEON PERFORMED LYSIS OF MASSIVE ADHESIONS FOR 2 HOURS AND ROBOTIC LYSIS OF ADHESIONS FOR AN ADDITIONAL 1 HOUR. ON POST-OPERATIVE DAY (POD) 1, THE PATIENT HAD MODERATE PAIN BUT WAS NOT IN ANY APPARENT DISTRESS. THE PATIENT DID NOT HAVE NAUSEA OR VOMITING, REBOUND, OR GUARDING. THE ABDOMEN WAS SOFT. AN X-RAY NOTED A NON-DILATED, NON-OBSTRUCTED BOWEL GAS PATTERN. NO LARGE AMOUNT OF FREE AIR WAS FOUND. ON POD 2, THE PATIENT HAD COMPLAINTS OF MILD PAIN OF THE ABDOMINAL INCISION AND ILEUS. THE PATIENT WAS DIAGNOSED WITH DEHYDRATION AND SINUS TACHYCARDIA. THE PATIENT WAS NOTED TO BE STABLE AND HIS WBC WAS 14.6. ON POD 3, THE PATIENT WAS ASSESSED BY A PHYSICIAN AND DIAGNOSED WITH ILEUS AND TACHYCARDIA. HIS WBC WAS 15.0. THAT SAME DAY, ANOTHER PHYSICIAN WAS CONSULTED FOR SEVERE SEPSIS WITH POSSIBLE IMPENDING SEPTIC SHOCK, SHORTNESS OF BREATH, AND ACUTE RESPIRATORY INSUFFICIENCY. THE PATIENT WAS TAKEN TO THE ICU WITH TACHYPNEA AND TACHYCARDIA. THE PATIENT WAS ABLE TO TALK IN FULL SENTENCES BUT WAS VISIBLY SHORT OF BREATH. THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN, FEVER, AND CHILLS. HIS ABDOMEN WAS DISTENDED AND THERE WERE DECREASED BOWEL SOUNDS. HOWEVER, THE PATIENT EXHIBITED NO GUARDING OR REBOUND TENDERNESS. HIS WBC WAS 13.3. THE PATIENT WAS DIAGNOSED WITH ACUTE RESPIRATORY INSUFFICIENCY, SEVERE SEPSIS, ABDOMINAL PAIN, ACUTE RENAL FAILURE, AND DYSPNEA. A CT-SCAN PERFORMED ON POD 3 SHOWED FREE ORAL CONTRAST AND FREE AIR IN INTRA-PERITONEAL SPACE. THAT SAME DAY, THE PATIENT WAS TAKEN TO THE OR FOR AN ACUTE ABDOMEN AND PERFORATED VISCUS WITH OPEN EXPLORATORY LAP. THE PATIENT UNDERWENT REPAIR OF A SMALL BOWEL ENTEROTOMY AND DRAINAGE OF INTRA-ABDOMINAL FLUID WITH WASHOUT. A LAPAROSCOPIC PROCEDURE WAS PERFORMED INITIALLY BUT CONVERTED TO A STANDARD MIDLINE INCISION DUE TO AN OBVIOUS PERFORATION IN THE LEFT MID-TO-LOWER QUADRANT. THE PATIENT HAD LOOPS OF SMALL BOWEL THAT WERE COMPLETELY FUSED AND COULD NOT BE SEPARATED. THE PATIENT WAS FOUND TO HAVE SIGNIFICANT PERITONITIS AND DENSE ADHESIONS. THE ENTEROTOMY WAS CLOSED AND 3 DRAINS WERE PLACED. BLOOD CULTURES WERE NEGATIVE. ABDOMINAL FLUID WAS POSITIVE FOR HEAVY GROWTH OF MORGANELLA MORGANII AND ENTEROBACTER AEROGENES. ON POD 4, THE PATIENT WAS ON A VENTILATOR AND BECAME PULSELESS AT 1230. CPR WAS INITIATED; HOWEVER, THE PATIENT WAS EXPIRED AT 1251. THE EXPIRATION NOTIFICATION NOTED THE IMMEDIATE CAUSE OF DEATH AS CARDIAC ARREST WITH AN UNDERLYING CAUSE OF DEATH AS CANCER OF COLON, COLECTOMY REPAIR OF ADHESIONS, AND HERNIA. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A BOWEL PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, DEVELOPED MULTIPLE POST-OPERATIVE COMPLICATIONS, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATION IS STILL 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": "11/29/2017" } ] }