{ "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": "2955842-2013-05614", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20131206", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121031", "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": "20131206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "633082", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131206", "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 A6.0P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20131206", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Cardiac Arrest", "Death", "Necrosis", "Pain", "Respiratory Distress", "Fluid Discharge" ] } ], "distributor_city": "", "date_report": "20131108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3504424", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140314", "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": "12496015", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI WAS PROVIDED WITH THE PATIENT'S DEATH CERTIFICATE. ACCORDING TO THE DEATH CERTIFICATE, THE MANNER OF DEATH WAS NATURAL AND THE CAUSE OF DEATH WAS REFRACTORY SHOCK. BASED ON THE ADDITIONAL INFORMATION, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THERE WAS NO INDICATION IN THE OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "20360080", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR ENDOMETRIAL CANCER, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, RIGHT PERIO-AORTIC LYMPH NODE DISSECTION, PARTIAL OMENTECTOMY, AND CYSTOSCOPY ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS DISCHARGED FROM THE OPERATING ROOM AFTER THE SURGICAL PROCEDURES WERE COMPLETED AND THE PATIENT WAS ADMITTED FOR POST-OPERATIVE CARE. ON POST-OP DAY 1 ((B)(6) 2012), THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN DURING HER FIRST ATTEMPT TO USE THE BATHROOM AND WAS GIVEN TORADOL FOR PAIN. LATER THAT SAME DAY, THE PATIENT WAS GIVEN DILAUDID 1 MG IV FOR CONTINUED SEVERE ABDOMINAL PAIN. APPARENTLY, THE PATIENT'S ABDOMINAL PAIN PERSISTED WITH INCREASING INTENSITY AND SHE WAS NO LONGER ABLE TO AMBULATE. BY 6:12 PM THAT SAME DAY, THE PATIENT WAS STARTED ON IV PATIENT-CONTROLLED ANALGESIA (PCA) FOR SEVERE ABDOMINAL PAIN. THROUGHOUT THE NIGHT, THE PATIENT REPORTEDLY EXPERIENCED INCREASING ABDOMINAL PAIN AND RESPIRATORY DISTRESS. ON POST-OP DAY 2 ((B)(6) 2012) AT 6:45 AM, THE PATIENT UNDERWENT A CT SCAN OF HER CHEST, ABDOMEN, AND PELVIS WHICH REVEALED HYPODENSE FLUID IN THE ABDOMEN AND PELVIS AND LARGE AMOUNTS OF INTRAPERITONEAL AND RETROPERITONEAL AIR. THE PATIENT'S RESPIRATORY DISTRESS WORSENED. SHE WAS TREATED WITH OXYGEN, IV FLUIDS, AND SUBSEQUENTLY TRANSFERRED TO THE CORONARY CARE UNIT. AT 9:25 AM THAT SAME DAY, THE PATIENT REPORTEDLY CODED. SHE WAS RESUSCITATED, INTUBATED, AND MAINTAINED ON A MECHANICAL VENTILATOR. AT 3:09 PM, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. THE LAPAROTOMY REVEALED FOUR ENTEROTOMIES IN THE JEJUNUM WHICH WERE LEAKING SUCCUSS ENTERICUS, AN ISCHEMIC ILEUM AND CECUM, AN ISCHEMIC LEFT COLON, A SMALL AMOUNT OF INTRAPERITONEAL STOOL, A LARGE VOLUME OF SANGUINEOUS STOOL, AND SMELLING DISCHARGE IN THE ABDOMINAL CAVITY. A PHYSICIAN PROCEEDED TO REPAIR THE FOUR ENTEROTOMIES, REMOVE THE NECROTIC PORTIONS OF THE SMALL AND LARGE INTESTINES, AND TEMPORARILY CLOSED THE PATIENT'S ABDOMEN. SHE WAS TRANSFERRED BACK TO THE CORONARY CARE UNIT IN CRITICAL CONDITION. ON POST-OP DAY 3 ((B)(6) 2012) AT 6:03 AM, THE PATIENT UNDERWENT A SECOND EXPLORATORY LAPAROTOMY. THE LAPAROTOMY REVEALED MORE NECROTIC TISSUE WITHIN THE ABDOMINAL CAVITY, INCLUDING THE REMAINDER OF THE COLON, NECROTIC TISSUE IN THE ABDOMINAL WALL MUSCULATURE AND THE LEFT PSOAS MUSCLE. AT 3:50 PM THAT SAME DAY, THE PATIENT WAS PRONOUNCED DEAD." }, { "mdr_text_key": "11637560", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUPPLEMENTAL HOSPITAL AND OFFICE MEDICAL REPORTS. A REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. FROM THE SURGEON'S OPERATIVE NOTE THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE INITIAL OPERATION. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS AT THE INITIAL SURGERY INCLUDED INTRABDOMINAL ADHESIONS. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, ADHESIONS IN THE RIGHT LOWER QUADRANT PREVENTED PLACEMENT OF A 12MM ASSISTANT PORT, AND , THE ADHESIONS IN THE RIGHT LOWER QUADRANT INVOLVING THE CECUM AND THE RIGHT PELVIC SIDEWALL WERE TAKEN DOWN WITH BLUNT AND SHARP DISSECTION. AFTER THE DA VINCI SURGERY, THE PATIENT PRESENTED AS FOLLOWS: ON (B)(6) 2012 THE PATIENT PRESENTED WITH INCREASING ABDOMINAL PAIN, DISTENTION, ACIDOSIS, RENAL FAILURE, HYPOTENSION AND TACHYCARDIA. SHE WAS TAKEN TO OR WITH FINDINGS OF PERITONITIS AND ISCHEMIA OF THE ILEUM, CECUM, AS WELL AS AREAS OF LEFT COLONIC ISCHEMIA. RESECTIONS OF ISCHEMIC BOWEL WERE NECESSARY. FOUR SMALL ENTEROTOMIES IN CLOSE PROXIMITY WERE FOUND IN THE DISTAL JEJUNUM LEAKING INTESTINAL CONTENTS INTO THE ABDOMINAL CAVITY. FECAL MATERIAL AND FOUL ODOR WERE PRESENT. THE ABDOMEN WAS CLOSED IN A MANNER TO EASILY OBSERVE FOR FURTHER ISCHEMIC CHANGE. ON (B)(6)2012 WHILE IN ICU, THE PATIENT DEVELOPED ACUTE DYSPNEA AND HYPOTENSION WITH SYSTOLIC B/P OF 50 MM/HG. SHE WAS SEVERELY OLIGURIC WITH MOTTLED AND COLD SKIN. SHE WAS RESUSCITATED WITH FLUIDS AND PRESSORS. SEVERE THROMBOCYTOPENIA WAS PRESENT WITH DIC. SHE WAS RETURNED TO THE OR AFTER INSPECTION OF THE WOUND REVEALED FURTHER ISCHEMIA. RESECTION OF ADDITIONAL BOWEL AS WELL AS ISCHEMIC MUSCLE TISSUE IN THE ABDOMINAL WALL AND LEG WERE DEBRIDED. AREAS OF BLACKENED SKIN AND DERMAL ISCHEMIC CHANGES WERE NOTED NEAR THE PATIENT'S HIP. SPECULATION INCLUDED IN THE SURGEON'S OPERATIVE NOTE COMMENTS WAS THAT THE PATIENT'S WIDESPREAD ISCHEMIA MAY BE DUE TO A MICROVASCULAR THROMBOSIS REACTION TO HEPARIN OR POSSIBLY DUE TO SEVERE INFECTION AND OVERWHELMING SEPSIS. THE HEPARIN WAS DISCONTINUED IN THE OR. THE PATIENT'S EXTREMELY POOR PROGNOSIS WAS REPORTED TO THE FAMILY. AFTER SURGERY, THE PATIENT WAS TRANSFERRED TO ICU IN CRITICAL CONDITION. SHE EXPIRED SHORTLY THEREAFTER THAT SAME DAY ON (B)(6) 2012." }, { "mdr_text_key": "20557439", "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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL DOCUMENT CLAIMS THAT THE PATIENT SUFFERED AN OPERATIVE COMPLICATION WHICH LED TO A POST-OPERATIVE ISCHEMIC BOWEL AND PROGRESSING SEPSIS, WHICH ULTIMATELY LED TO HER DEMISE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "03/07/2014;11/21/2014" } ] }