{ "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": "2955842-2013-04806", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120329", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559790", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": "", "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": "20250812", "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "107", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Diarrhea", "Hemorrhage/Blood Loss/Bleeding", "Injury", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440891", "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": "17155264", "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 DA VINCI TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY FOR HISTORY OF MENOMETRORRHAGIA, DYSMENORRHEA, AND UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE OPERATIVE FINDINGS WERE A (B)(6) UTERUS WITH MULTIPLE FIBROIDS. SEQUENTIAL IDENTIFICATION, CAUTERIZATION AND TRANSECTION OF THE INFUNDIBULO PELVIS LIGAMENTS, THE ROUGNON LIGAMENTS, THE BROAD LIGAMENTS. THE ARTERIAL DISSECTION AND CULPOTOMY WERE NOTABLE FOR A DIFFICULT DISSECTION DUE TO THE PRESENCE OF EXTENSIVE ADHESIONS, AND AN ABNORMALLY HIGH ROUTE FOR THE UTERINE ARTERY ON THE RIGHT SIDE. THE ARTERY WAS CAUTERIZED, AND AFTER DISSECTION IT WAS NOTED THAT THE URETER HAD BEEN IN CLOSE PROXIMITY DURING COAGULATION, AND THERE WAS CONCERN FOR THERMAL INJURY. THE REMAINDER OF THE OPERATION WAS COMPLETED, AND A UROLOGIC CONSULT WAS CALLED TO EVALUATE THE STATE OF THE URETER. THE CONSULT SURGEON PERFORMED A URETEROLYSIS FROM THE PELVIC BRIM TO THE INSERTION OF THE BLADDER, NOTED PERISTALSIS, ABSENCE OF ISCHEMIC CHANGES TO THE URETER, AND A BIT OF SPASM, AND RECOMMENDED NO STENT BE PLACED, BUT THE PATIENT BE WATCHED FOR SIGNS OF URETERAL DYSFUNCTION. THE UTERUS WAS THEN MORCELLATED AND REMOVED, A CYSTOSCOPY PERFORMED AND URINE NOTED FROM BOTH URETERAL ORIFICES. THE PATIENT WAS THEN CLOSED. ON (B)(6) 2012 A CT WITH CONTRAST OF THE ABDOMEN/PELVIS WAS PERFORMED NOTING A SLIGHTLY COMPLEX FLUID IN THE CUL-DE-SAC WITH NO WALL THICKENING TO SUGGEST AN ABSCESS. ON (B)(6) 2012, PATIENT UNDERWENT CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAMS, RIGHT URETEROSCOPY AND PLACEMENT OF RIGHT DOUBLE-J STENTS. THE LEFT SIDE SHOWED NO EXTRAVASATION, THE RIGHT SHOWED EXTRAVASATION 3 CM UP FROM THE UPJ AND NECROTIC TISSUE WAS OBSERVED WITH THE URETEROSCOPE. URETER WAS SUCCESSFULLY STENTED WITH DOUBLE J STENT. ON (B)(6) 2012, PATIENT UNDERWENT REPEAT CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAMS, AND RIGHT URETEROSCOPY AND REPLACEMENT OF RIGHT DOUBLE-J STENT AND PLACEMENT OF LEFT DOUBLE-J STENT FOR HISTORY OF RIGHT URETERAL INJURY AND LEFT HYDRONEPHROSIS. THE SITE OF PREVIOUS INJURY REMAINED NECROTIC. EXTRAVASATION WAS NOTED ON RETROGRADE CONTRAST INJECTION, SO STENT WAS REPLACED. THE LEFT SIDE SHOWED NARROWING, BUT NO SCARRING OR NECROSIS, SO A STENT WAS PLACED. ON (B)(6) 2012, PATIENT UNDERWENT SUCCESSFUL DAVINCI BILATERAL URETERAL REIMPLANTATION WITH A RIGHT PSOAS HITCH IN THE LEFT BOARI FLAP FOR A HISTORY OF RIGHT URETERAL EXTRAVASATION AND INJURY AND LEFT URETERAL OBSTRUCTION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE URETERS WERE ISOLATED AND DISSECTED FREE FROM THE SIDEWALL, TRANSECTED ABOVE THE LEVEL OF INJURY AND NARROWING RESPECTIVELY, SPATULATED AND ANASTOMOSED TO THE BLADDER OVER THE EXISTING STENTS. A BOARI FLAP WAS PERFORMED TO REDUCE TENSION ON THE ANASTOMOSES, AND THE SURGERY COMPLETED. ON (B)(6) 2013, PATIENT PRESENTED WITH SEVERAL MONTH HISTORY OF LUQ AND LLQ PAIN WITH BOWEL MOVEMENTS AND LOOSE STOOLS AND RECTAL BLEEDING. PREVIOUS COLONOSCOPY ON (B)(6) 2012 SHOWED HEMORRHOIDS BUT OTHERWISE NORMAL. NEGATIVE FOR C. DIFF, AND WAS FELT TO BE FLARE OF IBS. PATIENT WAS BEING MANAGED WITH DIET AND FIBER SUPPLEMENT. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "17366132", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT.A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED A URETER INJURY." } ], "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": "" } ] }