{ "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": "2955842-2013-03507", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130419", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458262", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "30 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Swelling", "Injury", "Constipation" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345332", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3868609", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES ON (B)(6) 2013. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, AND DYSPAREUNIA. ACCORDING TO THE OPERATIVE REPORT, THE UTERUS WAS REMOVED WITHOUT DIFFICULTY AND THE VAGINAL CUFF WAS CLOSED WITH A 0 V-LOC SUTURE. EXCELLENT HEMOSTASIS WAS CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF RIGHT FLANK AND ABDOMINAL PAIN, AND CONSTIPATION. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED MILD RIGHT HYDRONEPHROSIS AND A POSSIBLE DISTAL RIGHT URETERAL INJURY WITH CONTRAST EXTRAVASATION INTO A 4.5 X 6.5 CM PELVIC FLUID COLLECTION. THAT SAME DAY, A RIGHT PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED. ACCORDING TO PATIENT'S MEDICAL RECORDS, NO EXTRAVASATION OF CONTRAST WAS SEEN DURING THE PROCEDURE. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 WITH ORAL PAIN MEDICATIONS IN ADDITION TO OXYBUTYNIN FOR BLADDER SPASMS. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR 2 DAYS WITH A REPORTED COMPLAINT OF ABDOMINAL PAIN. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED THAT THE RIGHT NEPHROURETERAL STENT WAS PRESENT AND RELATIVELY WELL POSITIONED. NO SIGNIFICANT HYDROURETERONEPHROSIS WAS DETECTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013, AFTER HER PAIN HAD BEEN COMPLETELY CONTROLLED. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR 2 DAYS WITH A COMPLAINT OF RIGHT FLANK PAIN. A CT SCAN WITH AND WITHOUT CONTRAST OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED THAT THE PATIENT'S RIGHT-SIDED NEPHROURETERAL STENT WAS IN GOOD POSITION. NO HYDRONEPHROSIS OR EVIDENCE OF CONTRAST EXTRAVASATION FROM THE URETERS WAS FOUND. ON (B)(6) 2013, THE PATIENT UNDERWENT A NEPHROSTOGRAM AND RIGHT NEPHROURETERAL STENT EXCHANGE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE NOTED. THE NEPHROSTOGRAM REVEALED A 6 CM SEGMENT STRICTURE IN THE DISTAL RIGHT URETER AND RIGHT MILD HYDRONEPHROSIS. ON (B)(6) 2013, THE PATIENT UNDERWENT A PROCEDURE FOR PLACEMENT OF A BALLOON ANGIOPLASTY FOLLOWED BY REPLACEMENT OF THE RIGHT NEPHROURETERAL TUBE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "11196355", "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. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED AN INJURY TO THE RIGHT URETER DURING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURY OCCURRED." } ], "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": "" } ] }