{ "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": "2955842-2013-03145", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K021036", "date_of_event": "20090106", "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", "Consumer" ], "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": "409422", "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": "IS 1200", "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": "20250724", "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 S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Edema", "Pain", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305573", "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": "15874443", "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 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. THE PATIENT'S CURRENT CONDITION IS NOT KNOWN AT THIS TIME. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "15936055", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR SYMPTOMATIC FIBROID UTERUS. ACCORDING TO THE OPERATIVE REPORTS, THE SURGEON EVALUATED THE PATIENT'S PELVIS DURING THE DA VINCI SURGICAL PROCEDURE AND INDICATED THERE WAS A MARKEDLY ENLARGED MULTI-FIBROID UTERUS. AFTER THE VAGINAL CUFF WAS CLOSED, THE SURGEON NOTED A SMALL AMOUNT OF WELLING OF METHYLENE BLUE FROM THE LEFT PELVIC BRIM. THE SURGEON SUSPECTED A BLADDER OR URETHRAL INJURY AND UROLOGY WAS CONSULTED. WHEN UROLOGY ARRIVED, A CYSTOSCOPY WITH RETROGRADE PLACEMENT OF A GUIDEWIRE WAS PERFORMED AND REVEALED THERE WAS A LEFT URETERAL TRANSECTION CLOSE TO THE BLADDER NECK. THE FOLEY CATHETER WAS REPLACED IN THE URINARY BLADDER AND THE PATIENT WAS THEN UNDOCKED FROM THE DA VINCI SYSTEM. THE UROLOGIST EXAMINED THE PATIENT'S PELVIS THROUGH A SMALL AMOUNT OF DISSECTION IN THE CAMPER'S FASCIA. THE SMALL AMOUNT OF DISSECTION REVEALED THE TRANSECTED LEFT URETER AND CHARRING WAS OBSERVED AT THE END OF THE URETER. THE UROLOGIST REPAIRED THE URETERAL INJURY BY DIRECTLY IMPLANTING THE URETER INTO THE BLADDER. HE ALSO PERFORMED URETERAL NEOCYSTOSTOMY, URETERAL STENT PLACEMENT, AND BLADDER CLOSURE. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE VERY WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM. THE PATIENT WAS DISCHARGED 3 DAYS AFTER THE SURGICAL PROCEDURE. THE PATIENT WAS ADVISED TO HAVE A FOLEY BAG FOR 2-4 WEEKS. THE OPERATIVE REPORTS DO NOT HAVE ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAD HER URETERAL STENT REMOVED IN (B)(6) 2009. DURING A DOCTOR'S VISIT ON (B)(6) 2011, THE PATIENT REPORTED SHE HAD BEEN EXPERIENCING CHRONIC PAIN ON THE LEFT FLANK, LEFT ABDOMEN, LEFT LEG, AND BACK. THE PATIENT STATED THAT THIS PAIN STARTED SINCE HER HYSTERECTOMY PROCEDURE ON (B)(6) 2009. DURING THE EXAMINATION, THE SURGEON NOTED THAT THE PATIENT DID NOT HAVE ANY GROSS EDEMA OR ANY EVIDENCE OF ACUTE INJURY. THE PATIENT WAS ADVISED TO CONTINUE THE MEDICATION PAIN MANAGEMENT AND PHYSICAL THERAPY." } ], "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": "" } ] }