{ "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": "2955842-2013-04495", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131018", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130904", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131018", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "535796", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131018", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20131018", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Pain", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3419626", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131017", "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": "3882257", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A BOWEL PERFORATION AND REPORTED COMPLAINTS OF SEVERE PAIN ON POST-OP DAY 1. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT WAS FOUND TO BE SEPTIC. ON POST-OP DAY 3, AN OPERATION WAS PERFORMED TO REMOVE NECROTIC BOWEL. THE PATIENT SUBSEQUENTLY EXPIRED." }, { "mdr_text_key": "11161600", "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 COMPLICATION EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. ISI HAS ATTEMPTED TO CONTACT THE SURGEON AND RISK MANAGEMENT DEPARTMENT AT 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. ON (B)(4) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED INTRA-OPERATIVE COMPLICATIONS. THE CSR STATED THAT SHE SPOKE TO THE SURGEON AND SURGICAL STAFF AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR ALSO STATED THAT THE SURGEON INFORMED HER THAT THE DA VINCI SURGICAL PROCEDURE WENT FINE AND WAS VERY CUT AND DRY. ACCORDING TO THE CSR, THE PATIENT'S FAMILY MADE THE DECISION TO PULL THE PLUG ON (B)(6) 2013, A DAY AFTER AN OPERATION WAS PERFORMED TO REMOVE NECROTIC BOWEL. 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 PATIENT WAS FOUND TO HAVE A PERFORATED BOWEL ON POST-OP DAY 1 AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY PROCEDURE. THE PATIENT REPORTEDLY DEVELOPED SEPSIS AND PASSED AWAY. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S BOWEL INJURY OCCURRED." }, { "mdr_text_key": "11326842", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND BILATERAL PELVIC LYMPHADENECTOMY AND CYSTOURETHROSCOPY WITH PRE-OPERATIVE DIAGNOSIS OF ENDOMETRIAL CANCER ON (B)(6) 2013. AS PER THE OPERATIVE REPORT, THERE WAS NO EVIDENCE OF METASTATIC DISEASE AND NO DEEP INVASION WAS NOTED. THE UTERUS, TUBES AND OVARIES WERE FAIRLY NORMAL IN APPEARANCE. PRIOR TO THE HYSTERECTOMY, UPON OPENING THE RETROPERITONEAL SPACE, THE LYMPH- NODE-BEARING TISSUES FROM THE EXTERNAL ILIAC AND OBTURATOR AREAS WERE DISSECTED CAREFULLY. OBTURATOR NERVES WERE CAREFULLY IDENTIFIED, AND URETERS WERE CAREFULLY IDENTIFIED. AFTER REMOVAL OF THE UTERUS, THE VAGINAL CUFF WAS IRRIGATED, CLOSED AND ALL AREAS WERE REEXAMINED AND NOTED TO BE HEMOSTATIC. A CYSTOURETHROSCOPY WAS THEN PERFORMED. THE BLADDER WAS NOTED TO BE INTACT WITHOUT INJURY. A NEW FOLEY CATHETER WAS THEN PLACED. AT THAT POINT, ALL AREAS OF DISSECTION WERE REEXAMINED, NOTED TO BE HEMOSTATIC. THERE WAS NO EVIDENCE OF ANY BLEEDING OR INJURIES IN ANY AREA. THE PATIENT TOLERATED PROCEDURE WELL AND WAS TAKEN THE RECOVERY ROOM IN STABLE CONDITION. AS PER THE OPERATIVE REPORT, THERE IS NO INDICATION OF MALFUNCTION OR INJURY RELATED TO DA VINCI SURGICAL SYSTEM OR INSTRUMENTS DURING THIS PROCEDURE. AS PER THE MEDICAL RECORDS, ON POST-OPERATIVE DAY 1, THIS PATIENT EXPERIENCED DIAPHORESIS, HYPOTENSION AND TACHYCARDIA. A CHEST SCAN INDICATED A PULMONARY EMBOLUS. SHE WAS INITIALLY GIVEN A HEPARIN BOLUS AND TAKEN TO THE ICU FOR OBSERVATION; HOWEVER, SHE CONTINUED TO MANIFEST CLINICAL SYMPTOMS CONSISTENT WITH A SEPTIC PICTURE INCLUDING PERSISTENT HYPOTENSION, TACHYCARDIA, AND WORSENING ABDOMINAL PAIN. A CT OF THE ABDOMEN AND PELVIS SHOWED POCKETS OF FREE FLUID AND AIR AS WELL AS A THICKENING ALONG THE MUSCLE PLANES OF THE RIGHT LATERAL ABDOMINAL WALL. THE PATIENT WAS BROUGHT IN THE OR IN UNSTABLE CONDITION ON (B)(6) 2013 FOR AN EXTENSIVE DEBRIDEMENT OF THE RIGHT FLANK AND ABDOMEN, ABDOMINAL WASHOUT AND SMALL BOWEL RESECTION. THE PATIENT WAS NOTED TO HAVE EXTENSIVE NECROTIZING FACILITIES AND MYOSITIS. DURING THE POST-OPERATIVE PHASE, THIS PATIENT CONTINUED TO HAVE SEPTIC PHYSIOLOGY WITH ONGOING ADMINISTRATION OF BLOOD PRODUCTS AND LOT OF SUPPORT FOR NEXT 24-36 HRS. AND NEEDED TO BE PLACED ON VENTILATOR. THESE FINDINGS WERE DISCUSSED WITH PATIENT'S FAMILY MEMBERS AS WELL. ON (B)(6) 2013, PATIENT SHOWED SIGNS OF ABDOMINAL COMPARTMENT SYNDROME. THE PATIENT UNDERWENT REOPENING OF HER ABDOMEN WITH PLACEMENT OF ABDOMINAL WOUND VAC AND FURTHER DEBRIDEMENT OF THE WOUND. ON (B)(6) 2013, PATIENT WAS AURIC AND UNDERWENT ANOTHER ROUND OF DIALYSIS. HER CONDITION CONTINUED TO WORSEN, A CT SCAN INDICATED THICKENING OF COLON AND WAS BROUGHT BACK IN THE OPERATING ROOM FOR RE-EXPLORATION, WHICH NOTED VARIOUS AREAS OF ISCHEMIA IN THE BOWEL, PATCHY NECROSIS OF RECTO-SIGMOID AREA AND THERE WAS A SPREAD OF SEPSIS NOTED IN THE PERITONEAL SPACE. GIVEN THE PATIENT'S CRITICAL CONDITION, THE SURGEON TEAM NOTED THAT THIS WOULD NOT BE A SURVIVABLE INFECTION AND ELECTED TO BRING BACK THE PATIENT TO THE ICU IN A VERY UNSTABLE CONDITION. AFTER CONSULTATION WITH THE PATIENT'S FAMILY MEMBERS, THE DECISION WAS MADE NOT TO PROVIDE ANY ADDITIONAL MEDICAL TREATMENT. THE PATIENT EXPIRED DURING THE MORNING OF (B)(6) 2013." } ], "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": "12/04/2013" } ] }