{ "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": "2955842-2015-00365", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150227", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20130809", "reprocessed_and_reused_flag": "", "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": "20150228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "138074", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150227", "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": "0", "model_number": "IS2000", "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": "20150227", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Death", "Fistula", "Low Blood Pressure/ Hypotension", "Inflammation", "Renal Failure", "Sepsis", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4555312", "removal_correction_number": "", "number_devices_in_event": "", "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": "18790088", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SACROCOLPOPEXY, CYSTOSCOPY, FULGURATION OF BLADDER LESION, AND REPAIR OF A BLADDER LACERATION FOR CYSTOCELE AND BLADDER LESION ON (B)(6) 2013. THE PATIENT HAD A HISTORY OF BLADDER CANCER. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PRIOR TO THE UNDERGOING THE DA VINCI SURGICAL PROCEDURE, INFORMED CONSENT WAS OBTAINED. THE PATIENT HAD A HISTORY OF BLADDER CANCER, PRIOR ABDOMINAL SURGERIES, A HYSTERECTOMY, AND A CHOLECYSTECTOMY. AS A RESULT OF PRIOR SURGERIES, THE PATIENT HAD ADHESIONS. DURING THE SURGERY, AN OPENING IN THE BLADDER WAS NOTED AND REPAIRED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. THE ESTIMATED BLOOD LOSS WAS 100 ML. POST-OPERATIVELY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. AN UNSPECIFIED TIME LATER, THE PATIENT BECAME HYPOTENSIVE, APPEARED SEPTIC, AND DEVELOPED RENAL FAILURE. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, AND A SMALL BOWEL RESECTION WITH DIVERTING LOOP ILEOSTOMY. THE SURGEON RESECTED 75 CM OF SMALL BOWEL TO INCLUDE THE TWO AREAS OF BOWEL PERFORATION AS WELL AS TO INCLUDE AREAS OF INFLAMMATORY CHANGE AND SMALLER ENTEROTOMIES CAUSED BY MINIMAL MANIPULATION OF HER FRAGILE INFLAMED BOWEL. BY (B)(6) 2013, THE PATIENT REQUIRED FULL VENTILATORY SUPPORT. THE PATIENT REMAINED CRITICALLY ILL. ON (B)(6) 2013, INFECTIOUS DISEASE NOTED POST-OP COURSE COMPLICATED BY ONGOING SEPSIS, HYPOTENSION, MULTIPLE METABOLIC ABNORMALITIES, NON-OLIGURIC ACUTE RENAL FAILURE, LEUKOPENIA, HYPOCALCEMIA, HYPOKALEMIA, PROTEIN CALORIE MALNUTRITION, METABOLIC ACIDOSIS, AND (B)(6). THE PATIENT WAS SUSPECTED TO HAVE HEMODYNAMIC AND METABOLIC ISSUES DUE TO FULMINANT ABDOMINAL SEPSIS WITH MULTISYSTEM ORGAN FAILURE. ON (B)(6)2013, THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF ABDOMINAL WOUNDS X 2 WITH PLACEMENT OF WOUND VAC FOR NECROTIC TISSUE IN A LEFT LATERAL WOUND APPROXIMATELY 8 X 8 CM, AND FASCIAL DEHISCENCE WITH EXPOSED OMENTUM BUT NO BOWEL. NECROTIC FASCIAL TISSUE IN THE MIDLINE WAS ALSO DEBRIDED. ON (B)(6) 2013, AN ABSCESS WAS DRAINED UNDER CT FOR RIGHT PARACOLIC ABSCESS. ON 09/16/2013, THE DRAIN WAS REMOVED. ON (B)(6)2013, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY AND MALONEY DILATATION. THE PATIENT WAS DISCHARGED ON (B)(6)2013 TO ANOTHER FACILITY FOR INTENSIVE INPATIENT REHABILITATION. THE PATIENT INITIALLY DID WELL; HOWEVER, DURING THE EVENING OF (B)(6)2013, A FISTULA FORMATION WAS LEAKING STOOL INTO THE OPEN ABDOMINAL WOUND. THAT SAME DAY, THE PATIENT WAS ADMITTED WITH WOUND INFECTION AND TREATED CONSERVATIVELY. THE PATIENT RESPONDED WELL. ON (B)(6)2013, THE PATIENT WAS DISCHARGED TO (B)(6) FOR FURTHER WOUND CARE, MEDICATION MANAGEMENT, AND THERAPY. NO MEDICAL RECORDS AFTER (B)(6)2013 WERE PROVIDED." }, { "mdr_text_key": "19012739", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS COMPLAINT WAS INITIALLY SUBMITTED VIA ALTERNATIVE SUMMARY REPORTS (ASR) ON (B)(6) 2014 AND (B)(6) 2014. REFER TO MFR. REPORT 'S 2955842-2014-01197 AND 2955842-2014-05281 RESPECTIVELY. 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) 2013. 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." } ], "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": "" } ] }