{ "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": "2955842-2013-04846", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111109", "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": "560044", "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": "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": "20131031", "sequence_number_treatment": [ "DA VINC SI SURG SYS INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "77", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence", "Tissue Damage", "Obstruction/Occlusion", "No Code Available" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441334", "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": "11247564", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "3856493", "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 WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2011 FOR ENDOMETRIAL ADENOCARCINOMA OF THE UTERUS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE URETERAL REIMPLANTATION. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE SURGERY WAS NOTABLE FOR EXTENSIVE SIGMOID ADHESIONS TO THE LEFT PELVIC SIDEWALL AND LEFT ADNEXA. THE HYSTERECTOMY PROCEEDED WITH SEQUENTIAL LIGATION AND DIVISION OF THE ROUND LIGAMENTS, INFUNDBULO PELVIC LIGAMENTS WITH CARE TO IDENTIFY AND LOCALIZE THE URETER. URETEROLYSIS WAS PERFORMED DUE TO INVOLVEMENT AND INDURATION OF THE PERIRECTAL AND PERIVESICAL SPACES. THE BLADDER WAS SHARPLY DISSECTED AND THE UTERINE VESSELS AND THE CARDINAL LIGAMENTS LIGATED AND CUT. THE CULPOTOMY WAS MADE, AND THE UTERUS DELIVERED THROUGH THE VAGINA. THE VAGINAL CUFF WAS CLOSED WITH RUNNING SUTURES, AND THE PELVIC LYMPH NODE DISSECTION COMPLETED. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2011 THE PATIENT PRESENTED WITH URINE LEAKAGE, AND CT IMAGING IDENTIFIED A URETEROVAGINAL FISTULA. AS HER RADIAL MARGIN HAD BEEN POSITIVE FOR TUMOR, AND SHE HAD A NEWLY GROWING VAGINAL LESION, THE DECISION WAS MADE TO DELAY REIMPLANTATION UNTIL AFTER CHEMOTHERAPY AND RADIATION. SHE WAS REFERRED TO A UROLOGIST FOR CONSULT FOR TREATMENT OPTIONS. ON (B)(6) 2011 THE CONSULTING UROLOGIST PERFORMED A CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAM AND RIGHT DIAGNOSTIC URETEROSCOPY, AND DETERMINED THE RIGHT URETER WAS BLOCKED AND WAS UNABLE TO PASS A WIRE. A NEPHROSTOMY TUBE WAS PLANNED FOR THE NEXT DAY (RECORD UNAVAILABLE) AND THE CASE ENDED. UPON VAGINOSCOPY, A 3X4 CM FAST GROWING TUMOR WAS IDENTIFIED ON THE CUFF. ON (B)(6) 2012 CT IMAGING SHOWED A NEW MASS BELOW THE UMBILICUS, NEPHROSTOMY TUBE IN PLACE ON THE RIGHT KIDNEY WITH NO OBSTRUCTION, SMALL AMOUNT OF FREE FLUID IN THE ABDOMEN. ON (B)(6) 2012 AFTER COMPLETING THE PLANNED COURSE OF RADIATION AND CHEMOTHERAPY, THE PATIENT RETURNED FOR EXCISION OF THE UMBILICAL AND VAGINAL MASSES AND DAVINCI URETERAL REIMPLANTATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. OF NOTE, THERE WERE DENSE DESMOPLASTIC REACTIONS AND ADHESIONS THROUGHOUT THE ABDOMEN, AND THE URETER WAS HEAVILY ENCASED IN DESMOPLASTIC REACTION. THE URETER WAS TRANSECTED ABOVE THE REACTIVE AREA, AND IMPLANTED IN THE BLADDER WHICH REQUIRED A BOARI FLAP TO PROVIDE A TENSION FREE ANASTOMOSIS. THE BLADDER ANASTOMOSIS WAS FLUID TESTED, AND THE PROCEDURE FINISHED WITHOUT COMPLICATION. ON (B)(6) 2013 POSTOPERATIVE FOLLOW UP THE PATIENT WAS NOTED TO BE DOING WELL. THERE WAS NO EVIDENCE OF EXTRAVASATION ON CYSTOGRAM, AND THE NEPHROSTOMY TUBE WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THIS DATE." } ], "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": "" } ] }