{ "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": "2955842-2013-04787", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130123", "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": "560165", "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": "20250808", "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 SURG SYS INSTRMNTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "28 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cyst(s)", "Pain", "Burn, Thermal", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440352", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "3897733", "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 THAT UNDERWENT A DA VINCI SI HYSTERECTOMY AND CYSTOSCOPY FOR ENDOMETRIAL HYPERPLASIA, MENORRHAGIA AND DYSMENORRHEA ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, AND THE PROCEDURE REPORTS FOR URETERAL STENT PLACEMENT AND STENT REMOVAL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE SURGERY WAS PERFORMED WITH FENESTRATED BIPOLAR AND AN UNSTATED INSTRUMENT WITH ROUTINE CAUTERIZATION AND TRANSECTION OF UTERO-OVARIAN LIGAMENTS, ARTERIES AND FALLOPIAN TUBES WITH VAGINAL DELIVERY OF THE UTERUS, CAUTERY OF BLEEDERS ON THE VAGINAL VAULT, AND CLOSURE WITH BARBED SUTURE. UPON ROUTINE CYSTOSCOPY WITH INDIGO CARMINE, IT WAS NOTED THAT THERE WAS NO EFFLUX FROM THE RIGHT URETERAL ORIFICE. A UROLOGIST WAS CONSULTED WHO PERFORMED BILATERAL RETROGRADE PYELOGRAMS. HE PLACED A 6 FRX26 CM DOUBLE PIGTAIL STENT IN THE RIGHT URETER BECAUSE OF THE CONCERN THAT THE HYDROURETERAL NEPHROSIS INDICATED THERMAL INJURY TO THE URETER. THE SURGERY WAS COMPLETED, AND PATIENT DISCHARGED WITH STENT. ON (B)(6) 2013, PATIENT HAD A CYSTOSCOPY WITH STENT REMOVAL AND RIGHT RETROGRADE PYELOGRAM FOR HISTORY OF URETERAL INJURY. THE STENT WAS REMOVED WITHOUT INCIDENT, AND THE PYELOGRAM SHOWED NO EVIDENCE OF FISTULA, STRICTURE, OR FILLING DEFECTS. ON (B)(6) 2013, PATIENT UNDERWENT PLANNED DAVINCI URETERAL RECONSTRUCTION, BIOPSY OF LESIONS TO RULE OUT ENDOMETRIOSIS AND URETERAL INJECTION OF INDOCYANINE GREEN FOR HISTORY OF SUSPECTED THERMAL INJURY TO URETER AND PERSISTENT PAIN AND HYDRONEPHROSIS. DURING SURGERY, LYSIS OF ADHESIONS WAS PERFORMED AND PRESENCE OF CHOCOLATE CYSTS NOTED IN THE DEEP PELVIS, OVARY AND LEFT URETER. THESE LESIONS WERE BIOPSIED. ARTIFACT OF THERMAL INJURY TO THE URETER WAS NOTED, AND SEVERE FIBROSIS WAS NOTED IN ANOTHER SEGMENT OF THE URETER, BUT NO KINKING. THE INTRAOPERATIVE DECISION WAS MADE TO PERFORM A URETEROLYSIS RATHER THAN A RECONSTRUCTION. THE PATIENT'S DISCHARGE CONDITION AND POSTOPERATIVE COURSE WERE UNAVAILABLE." }, { "mdr_text_key": "11397648", "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. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL 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": "" } ] }