{ "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": "2955842-2016-00032", "type_of_report": [ "Followup" ], "product_problem_flag": "", "date_received": "20160113", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131121", "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": "20160113", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "22227", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160113", "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", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20160113", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Death", "Burn(s)", "Death" ] } ], "distributor_city": "", "date_report": "20151217", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5365298", "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": "39770813", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE OPERATIVE REPORT OF THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE PERFORMED ON (B)(6) 2013 FOR ADENOCARCINOMA OF THE PROSTATE. PER THE OPERATIVE REPORT, THERE IS NO INDICATION THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED. AFTER THE PROSTATE WAS REMOVED AND PLACED INTO A RETRIEVAL BAG, THE SURGEON NOTED THE FOLLOWING: WE THEN METICULOUSLY INSPECTED THE PROSTATIC BED AND CHECKED FOR ANY POSSIBLE RECTAL INJURY. WE FILLED THE PELVIS WITH FLUID AND INJECTED AIR IN THE RECTUM VIA A RED RUBBER CATHETER AND WE COULD NOT IDENTIFY ANY BUBBLING. WE THEN INSERTED AN EA SIZER INTO THE RECTUM WHICH COULD BE PASSED HIGHER UP AND AGAIN WE COULD NOT IDENTIFY ANY EVIDENCE OF RECTAL INJURY. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 500 ML. ISI WAS ALSO PROVIDED WITH AN OPERATIVE REPORT OF THE FOLLOWING PROCEDURES PERFORMED ON (B)(6) 2013: EXPLORATORY LAPAROTOMY; SIGMOID COLECTOMY WITH END ILEOSTOMY; FLEXIBLE SIGMOIDOSCOPY; THREE-WAY FOLEY CATHETER IRRIGATION; AND PERITONEAL LAVAGE WITH 6 LITERS OF NORMAL SALINE. PER THE OPERATIVE REPORT, THE PATIENT DEVELOPED SOME DIFFICULTY WITH URINATION AFTER UNDERGOING THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE 4 DAYS EARLIER. DURING THE SURGICAL PROCEDURE, A LARGE AMOUNT OF STOOL WAS FOUND IN THE PATIENT'S ABDOMEN WHICH WAS LAVAGED OUT. AFTER A PERFORATION WAS IDENTIFIED APPROXIMATELY 10 CM FROM THE ANAL VERGE, THE SURGEON NOTED, WE THEN SET ABOUT MOBILIZING THE SIGMOID TO BRING IT UP FOR DIVERSION AND CONVERTING OSTOMY. WE LEFT THE MOST DISTAL END OF THE SIGMOID IN PLACE, TRANSECTED ACROSS THIS AND LEFT WITH OUR GREEN LOAD GI STAPLER. WE THEN USED THE LIGASURE AND BOVIE CAUTERY TO MOBILIZE ALONG THE WHITE LINE OF TOLDT AND TAKE DOWN THE MESENTERY ACROSS WHICH WAS TRANSECTED. UNFORTUNATELY, DURING TRANSECTION OF THE MESENTERY, APPROXIMATELY 10 CM OF SMALL BOWEL BECAME FRANKLY DUSKY WHICH WE WENT AHEAD AND RESECTED WITH AN ENDO GIA STAPLER AND MADE A COLOTOMY AT THE SAME TIME OPENING THE COLON AT THIS TIME AND SUCKING OUT ANY ADDITIONAL AIR FROM THE COLON THAT WAS INTRODUCED DURING OUR SIGMOIDOSCOPY. WITH THIS COMPLETED IN THE RE-RESECTED COLON, WE THEN TOOK DOWN THIS MESENTERY AND THIS SPECIMEN OF SIGMOID COLON WAS THEN PASSED OFF THE FIELD. THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED BACK TO THE ICU IN STABLE BUT CRITICAL CONDITION. WITHIN THE OPERATIVE REPORT, THE SURGEON DID NOT MENTION ANY EVIDENCE OF A BURN INJURY AS ALLEGED BY THE PLAINTIFF'S ATTORNEY. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A PROBABLE BURN INJURY TO HIS BOWEL WHICH LATER CAUSED HIS DEATH. HOWEVER, THE MEDICAL RECORDS PROVIDED DO NOT SHOW ANY INDICATION THAT A BURN INJURY OCCURRED TO THE PATIENT'S BOWEL. ALSO, AT THIS TIME, THE CAUSES OF THE PATIENT'S RECTAL PERFORATION AND SUBSEQUENT DEATH ARE UNKNOWN." }, { "mdr_text_key": "35917549", "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 INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A PROBABLE BURN INJURY TO HIS BOWEL WHICH LATER CAUSED HIS DEATH. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED INTRA-OPERATIVE BOWEL INJURY AND SUBSEQUENT DEATH IS UNKNOWN." }, { "mdr_text_key": "35917550", "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 THAT UNDERWENT A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE ON (B)(6) 2013. DURING THE SURGICAL PROCEDURE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A PROBABLE BURN INJURY TO HIS BOWEL WHICH LATER CAUSED HIS DEATH. ISI WAS NOT PROVIDED WITH THE DA VINCI-ASSISTED OPERATIVE REPORT OR ANY MEDICAL RECORDS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "03/01/2016" } ] }