{ "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": "Injury", "report_number": "2955842-2013-04839", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100817", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559164", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": "HEALTH PROFESSIONAL", "model_number": "IS2000, A5.1P8", "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": "20250826", "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": "20131031", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Adhesion(s)", "Erosion", "Gastritis", "Hemorrhage/Blood Loss/Bleeding", "Ischemia", "Nausea", "Perforation", "Pneumothorax", "Vomiting", "Injury", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441282", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "11247111", "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 OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. 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 PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE." }, { "mdr_text_key": "3946733", "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 S CYSTOPROSTATECTOMY, BILATERAL PELVIC LYMPHNODE DISSECTION AND ILEAL CONDUIT AND URINARY DIVERSION PROCEDURE ON (B)(6) 2010 FOR RECURRENT T1G3 BLADDER CANCER WHICH HAD BEEN PREVIOUSLY TREATED WITH BCG AND THEN TRANSURETHRAL RESECTION ON (B)(6) 2010. AN INTRAOPERATIVE RECTAL INJURY NECESSITATED A RECTAL INJURY REPAIR. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND NOTES ON HIS SUBSEQUENT PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PORTS WERE PLACED, AND THE URETERS MOBILIZED DOWN TO THE LEVEL OF THE BLADDER, CLIPPED, DIVIDED AND SET ASIDE. VASCULAR PEDICLES WERE STAPLED AND DIVIDED, FREEING THE BLADDER. THE PROSTATE DOWN TO THE URETHRA WAS DISSECTED, AND THE URETHRA CLIPPED. DURING THE POSTERIOR DISSECTION OF THE PROSTATE IT WAS NOTED THAT AN OUTPOUCHING ON THE ANTERIOR SURFACE OF THE RECTUM HAD BEEN AMPUTATED AND THE RECTUM ENTERED. THERE WERE CLEAN EDGES ON THE RECTAL DEFECT, SO THE SURGEON PERFORMED A PRIMARY REPAIR, AND CALLED A CONSULT FROM A GENERAL SURGEON TO INSPECT THE REPAIR WHICH WAS PRONOUNCED TO BE ADEQUATE. THE SPECIMEN WAS PLACED IN AN ENDOCATCH BAG, AND THE LYMPHADENECTOMY PERFORMED WITH THE REMOVAL OF ALL TISSUE FROM THE INTERNAL ILIAC ARTERIES TO THE CIRCUMFLEX VEIN TO THE LEVEL OF THE OBTURATOR NERVE WITH COMPLETE SKELETONIZATION OF THE ILIAC ARTERIES, VEINS AND THE OBERATOR NERVE. THE ROBOTIC PORTION WAS COMPLETE, AND THE PATIENT OPENED WITH A MIDLINE INCISION TO REMOVE THE SPECIMEN AND CREATE THE ILEAL CONDUIT WITH 15 CM OF ILEUM DIVIDED WITH A STAPLER. THE ILEUM WAS RECONNECTED WITH A SIDE TO SIDE ANASTOMOSIS, AND THE URETERS WERE ANASTOMOSED TO THE EXCISED ILEUM, AND THE STOMA DEVELOPED AND BROUGHT TO THE SKIN AT THE INCISION. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT TAKEN TO RECOVERY AND DISCHARGED IN STABLE CONDITION ON (B)(6) 2010. ON (B)(6) 2010 PATIENT PRESENTED WITH ABDOMINAL PAIN AND IMAGING SHOWED FREE INTRAABDOMINAL AIR AND PELVIC FLUID. HE UNDERWENT AN EXPLORATORY LAPAROTOMY WHICH FOUND A CECAL INJURY AND FECAL MATTER IN THE PERITONEAL CAVITY. THE CECUM WAS ADHERENT TO THE SIDE WALL, AND TAKEDOWN OF THE CECUM RESULTED IN AN ILIAC VEIN INJURY WHICH WAS REPAIRED DIRECTLY. THE PROCEDURE CONSISTED OF A TAKEDOWN OF INTRAABDOMINAL ADHESIONS, PARTIAL CECUMECTOMY (MISTRANSCRIBED IN THE OPERATIVE REPORT AS CYSTECTOMY) AND DIVERTING ILEOSTOMY, AND ILIAC VEIN REPAIR. THE CECUM SPECIMEN WAS NOTED AS HAVING A FOCAL HEMORRHAGIC AREA WITH A PERFORATION. THE PATIENT WAS TAKEN TO THE PACU POST OPERATIVELY, BUT WAS RETURNED TO THE OR ON THE SAME DAY FOR ISCHEMIA OF THE RIGHT LOWER EXTREMITY THOUGHT TO BE A RESULT OF THE ARTERIAL CLAMPING DURING THE ILIAC VENOUS REPAIR. VASCULAR SURGERY PERFORMED AN AORTOGRAM AND SUCCESSFUL FOGARTY CATHETER THROMBOLECTOMY OF THE RIGHT EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. THE PATIENT HAD A DIFFICULT POST OPERATIVE COURSE WITH POOR WOUND HEALING AND ILIAC VEIN THROMBUS FOR WHICH HE WAS STARTED ON COUMADIN. IN ADDITION ON 09/06/2010 CT IMAGING SHOWED A LYMPHOCELE AND PELVIC FLUID COLLECTION WHICH WERE DETERMINED TO BE PELVIC ABSCESSES AND WERE MANAGED WITH IR PLACED DRAINS. HE WAS DISCHARGED IN STABLE CONDITION ON 09/10/2010 ON ANTIBIOTICS AND COUMADIN WITH ILEOSTOMY, UROSTOMY AND TWO PELVIC DRAINS. ON 09/16/2010 PATIENT PRESENTED WITH NAUSEA VOMITING AND ACUTE RENAL FAILURE. CT IMAGING SHOWED BILATERAL ENLARGEMENT OF THE ADRENAL GLANDS CONSISTENT WITH HEMORRHAGE, BUT REDUCED PELVIC ABSCESSES. PATIENT WAS TAKEN TO OPERATING ROOM FOR A GREENFIELD FILTER PLACEMENT. HIS ANTICOAGULATION WAS STOPPED. ON (B)(6) 2010 PATIENT HAD A DI FEEDING TUBE PLACED SECONDARY TO CONCERNS ABOUT NUTRITION. ON (B)(6) 2010 PATIENT DEVELOPED A BILATERAL PNEUMOTHORAX FOR WHICH HE INITIALLY DECLINED TO BE TREATED, BUT HAD PLEURAL PIGTAIL CATHETERS PLACED ON (B)(6) 2010. ON (B)(6) 2010 HE WAS DISCHARGED HOME IN STABLE CONDITION. ON (B)(6) 2010 PATIENT WAS HOSPITALIZED FOR EROSIVE GASTRITIS AND MALNOURISHMENT AND ACUTE ADRENAL INUICIENY. HE WAS STARTED ON STEROIDS. HE WAS DISCHARGED HOME ON (B)(6) 2010. ON (B)(6) 2010 AT AN OUTPATIENT VISIT HE SEEMED TO BE DOING WELL AND WAS ADDRESSING HIS MALNUTRITION AND GAINING STRENGTH. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THIS NOTE." } ], "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": "" } ] }