{ "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": "2955842-2013-03142", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120419", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410244", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI 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", "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": "20250825", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SUG SYSTEM INSTRUMENT, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Fistula", "Hematoma", "Inflammation", "Swelling", "Discomfort" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305547", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "20869651", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED IN 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 DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "20633372", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY, EXTENSIVE LYSIS OF ADHESIONS AND RIGHT URETEROLYSIS ON (B)(6) 2012. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S OPERATIVE REPORT (OP) FOR THE SURGICAL PROCEDURE ON (B)(6) 2012 INDICATED THAT THE PATIENT UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY DUE TO UTERINE FIBROIDS, MENOMETRORRHAGIA AND MILD CERVICAL DYSPLASIA. BASED ON THE INFORMATION IN THE PATIENT'S OP, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE SURGEON DESCRIBES IN THE OP THAT THERE WERE EXTENSIVE ADHESIONS AND HE DECIDED TO PERFORM EXTENSIVE LYSIS OF ADHESIONS BETWEEN THE BLADDER AND THE ANTERIOR PART OF THE LOWER UTERINE SEGMENT. THE SURGEON STATES IN THE OP THAT THE RIGHT URETER WAS VERY CLOSE TO THE LEVEL OF DISSECTION. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM WITH STABLE VITAL SIGNS AND IN SATISFACTORY CONDITION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT A ROUTINE FOLLOW UP APPOINTMENT ON (B)(6) 2012, THE PATIENT INDICATED THAT SHE WAS EXPERIENCING PELVIC PRESSURE IN THE MIDLINE AND THAT SHE FELT THAT SHE HAD TO URINATE ALL THE TIME. THE PATIENT WAS REFERRED BACK TO THE HOSPITAL AS AN OUTPATIENT. PER MEDICAL RECORDS, THE PATIENT WENT TO THE EMERGENCY ROOM (B)(6) 2012 AND WAS ADMITTED TO THE HOSPITAL WITH FEVER, AND RIGHT HYDRONEPHROSIS. CT SCAN SHOWED PELVIC FLUID COLLECTION, POSSIBLE HEMATOMA. TRIPLE IV ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THE PATIENT UNDERWENT CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAPHY, RIGHT URETERAL STENT INSERTION, AND EVACUATION OF VAGINAL CUFF HEMATOMA ON (B)(6) 2012. THE CONTRAST EXITED EITHER POSTEROMEDIALLY OR MEDIALLY FROM THE URETER VERY CLOSE TO THE PATIENT'S BLADDER AND INTO THE VAGINA. THE SURGEON WAS UNABLE TO GET CONTRAST INTO THE MORE PROXIMAL URETER AND THE SURGEON WAS UNABLE TO SUCCESSFULLY INTUBATE THE PROXIMAL URETER. THE PATIENT'S BLADDER DRAINED AT THE CONCLUSION OF THE CASE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY IMMEDIATE COMPLICATIONS. THE OPERATIVE REPORT STATED A POST OP DIAGNOSIS OF URETEROVAGINAL FISTULA. ON (B)(6) 2012, THE PATIENT UNDERWENT AN OPEN RIGHT URETERONEOCYSTOSTOMY TO REPAIR THE RIGHT URETERAL STRICTURE. THE OP FROM THIS SURGERY NOTES THAT THE RIGHT PARAVESICAL SPACE WAS FOUND TO BE VERY STUCK AND EXHIBITED INFLAMMATION. THE PATIENT'S RIGHT URETER WAS ANASTOMOSED TO HER BLADDER AND A URETERAL STENT WAS PLACED INTO THE COLLECTING SYSTEM. AFTER COMPLETION OF THE PROCEDURE, GOOD HEMOSTASIS WAS NOTED. PER THE INFORMATION IN THE OP, THE PATIENT TOLERATED THE OPEN PROCEDURE WITHOUT ANY IMMEDIATE COMPLICATIONS." } ], "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": "" } ] }