{ "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": "2955842-2013-04764", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20130221", "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": "558989", "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", "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": "20250824", "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 SYSTEM INSTRUMENTS AND ACCESSORIES&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "49", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3439913", "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": "3902250", "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 DAVINCI HYSTERECTOMY AND LYSIS OF ADHESIONS FOR A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING, PELVIC PAIN, UTERINE FIBROID, AND PRESENCE OF EXTENSIVE ABDOMINAL/PELVIC ADHESIONS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE URETERAL REIMPLANTATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS NOTABLE FOR THE EXTENSIVE ABDOMINAL ADHESIONS FROM THE ANTERIOR PORTION OF THE UTERUS TO THE ANTERIOR WALL OF THE ABDOMEN WHICH HAD TO BE TAKEN DOWN WITH AN ENSEAL LIGATOR BEFORE THE HYSTERECTOMY COULD START. THE UTERINE CORNEAL ATTACHMENTS, AND UTERINE VESSELS WERE CAUTERIZED AND CUT, THE BLADDER WAS BLUNTLY AND SHARPLY DISSECTED INFERIORLY AND THE CULPOTOMY COMPLETED. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, AND THE VAGINAL CUFF CLOSED WITH V-LOCK SUTURES. THE CYSTOSCOPY WAS PERFORMED WITH IV INDIGO CARMINE, AND BOTH URETERAL ORIFICES WERE SEEN EJECTING DYE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2013 PATIENT PRESENTED WITH URINE DRAINING FROM HER VAGINA. CT IMAGING SHOWED FLUID COLLECTION IN THE PELVIS CONCERNING INITIALLY FOR AN ABSCESS AND MILD HYDRONEPHROSIS IN THE RIGHT PELVIC KIDNEY. THE PATIENT UNDERWENT A CYSTOSCOPY AND RETROGRADE PYELOGRAM WHICH SHOWED EXTRAVASATION DISTALLY FROM THE RIGHT URETER, BUT THEY WERE UNABLE TO CANNULATE THE PROXIMAL URETER, AND UNABLE TO PASS NEPHROSTOMY TUBES AS THE PATIENT'S KIDNEY WAS MALROTATED AND IN A PELVIC POSITION. ON (B)(6) 2013 PATIENT UNDERWENT A DAVINCI RIGHT URETERAL REIMPLANTATION, LYSIS OF ADHESIONS, BILATERAL RETROGRADE PYELOGRAMS, CYSTOGRAM, AND CYSTOSCOPY TO TREAT HER RIGHT URETERAL INJURY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. IT WAS NOTED THERE WERE EXTENSIVE ADHESIONS FROM HER PREVIOUS SURGERY WHICH TOOK 30 MINUTES TO TAKE DOWN. THE VAGINAL CUFF WAS REPAIRED, THE RIGHT URETER DISSECTED DOWN TO THE BLADDER, THE BLADDER MOBILIZED AND TACKED UP WITH A PSOAS HITCH. AN ANASTOMOSIS WAS PERFORMED AND SHORTENED DOUBLE-J STENT PLACED BECAUSE OF THE PELVIC LOCATION OF THE KIDNEY. THE BLADDER WAS DISTENDED TO CHECK FOR LEAKS, AND THE SURGERY COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2013 THE PATIENT PRESENTED FOR STENT REMOVAL AND WAS DOING WELL. THE STENT WAS REMOVED WITHOUT DIFFICULT. NO FURTHER RECORDS ARE AVAILABLE." }, { "mdr_text_key": "11100030", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUFFERED A URETER INJURY AFTER UNDERGOING A DA VINCI HYSTERECTOMY 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": "" } ] }