{ "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": "2955842-2013-04910", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100825", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562816", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Anemia", "Fistula", "Incontinence", "Unspecified Infection", "Tachycardia", "Abnormal Vaginal Discharge", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444139", "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": "3900653", "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 A DA VINCI SI RADICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY FOR CERVICAL CANCER STAGE IB2 ON (B)(6) 2010. AFTER INITIAL DEFINITIVE CHEMORADIATION FOR ONE WEEK IN (B)(6) 2010 THE PATIENT CHANGED HER MIND AND DESIRED SURGICAL TREATMENT. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: UROLOGY CLINIC NOTE (B)(6) 2010, (B)(6) 2011, DISCHARGE SUMMARY (B)(6) 2011. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER PLACEMENT OF AN APPLE COLPOTOMIZER, A PNEUMOPERITONEUM WAS INSTALLED THROUGH AN OPEN ACCESS. TAKE DOWN OF OMENTAL ADHESIONS WITH ENDO-SHEARS AFTER PLACEMENT OF ONE ADDITIONAL PORT WAS PERFORMED. THEN, THE REMAINING PORTS WERE PLACED AND THE PATIENT WAS DOCKED TO THE ROBOT. DEVELOPMENT OF THE PARAVESICAL AND PARARECTAL SPACES, AND IDENTIFICATION AND DISSECTION OF BOTH URETERS DOWN TO THE BLADDER TRIGONUM WERE PERFORMED. THE SURGEON PERFORMED DISSECTION OF THE UTERINE VESSELS WITH BIPOLAR CAUTERY AND TAKE DOWN OF THE BLADDER OFF THE UPPER VAGINA. CIRCUMFERENTIAL COLPOTOMY 3CM DISTAL TO THE CERVICO-VAGINAL JUNCTION AROUND THE APPLE COLPOTOMIZER WAS PERFORMED. THE SURGEON THEN PERFORMED TRANSVAGINAL DELIVERY OF THE UTERUS, OVARIES AND TUBES, AS WELL AS PELVIC LYMPH NODES AFTER ANATOMIC LYMPH NODE DISSECTION. CUFF CLOSURE WITH 5 VICRYL 0 FIGURE-OF-EIGHT STITCHES. 4-5 DAYS AFTER SURGERY THE PATIENT NOTED VAGINAL DRAINAGE. HER SURGEON NOTED PURULENCE AND POSSIBLE CLOUDY URINE DRAINING FROM THE VAGINA. AN INITIAL CYSTOGRAM ON SEPTEMBER 3 FAILED TO SHOW A VESICOVAGINAL FISTULA NOR DID A BARIUM ENEMA AT THAT TIME SHOW ANY ABNORMALITIES. THE PATIENT WAS TREATED FOR PELVIC INFECTION. ON REPEAT CYSTOGRAM APPROXIMATELY 2 WEEKS LATER, A VESICOVAGINAL FISTULA WAS DEMONSTRATED AND COULD BE APPRECIATED ON PELVIC EXAM. FOLEY CATHETER WAS PLACED WITHOUT IMPROVEMENT IN LEAKAGE, AND SUBSEQUENTLY BILATERAL NEPHROSTOMY TUBES WERE PLACED IN (B)(6). SHE WAS REFERRED TO A PHYSICIAN AT THE END OF OCTOBER WHO PERFORMED A FLEXIBLE CYSTOSCOPY WHICH CONFIRMED A LARGE VESICOVAGINAL FISTULA AT THE LEVEL OF THE TRIGONE AT LEAST 2 CM IN WIDTH WITH INABILITY TO VISUALIZE HER RIGHT OR LEFT URETERAL ORIFICE. ON (B)(6) 2010, REFERRAL TO A UNIVERSITY UROLOGY CLINIC FOR TREATMENT OF A LARGE VESICOVAGINAL FISTULA INVOLVING MOST OF THE TRIGONE AND WHAT APPEARS TO BE BOTH URETERAL ORIFICES. THE DECISION WAS MADE TO ATTEMPT A PRIMARY REPAIR OF THE FISTULA AFTER AT LEAST A 5-6 MONTH RECONVALESCENCE PERIOD. ON (B)(6) 2011: BILATERAL URETERAL REIMPLANTS, TRANSABDOMINAL VESICOVAGINAL FISTULA REPAIR WITH OMENTAL INTERPOSITION GRAFT, BILATERAL SINGLE-J URETERAL STENT PLACEMENT, BILATERAL NEPHROURETEROGRAMS. AN UNEXPECTED AMOUNT OF RADIATION CHANGES IN THE PELVIS WITH SIGNIFICANT PERIURETERAL FIBROSIS AND PERITONEAL THICKENING WERE NOTED LEADING TO A 4 HOUR URETEROLYSIS AND OVER 8-HOUR OVERALL OPERATIVE TIME. THE POSTOPERATIVE COURSE WAS COMPLICATED BY EPISODES OF ATRIAL TACHYCARDIA, ANEMIA THAT REQUIRED TRANSFUSION OF 2 RBC'S AND A PROLONGED ILEUS THAT REQUIRED TOTAL PARENTAL NUTRITION. DISCHARGE HOME ON (B)(6) 2011 (POSTOPERATIVE DAY 10) WHEN SHE WAS ABLE TO TOLERATE REGULAR DIET. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11251249", "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(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE." } ], "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": "" } ] }