{ "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": "2955842-2012-00212", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120516", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20110601", "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": "20120803", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120516", "brand_name": "DA VINCI S 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 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20120516", "sequence_number_treatment": [ "DA VINCI S INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Injury", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2577302", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120416", "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": "2652178", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON APRIL 16, 2012 ISI RECEIVED A LEGAL SUMMONS INDICATING ON (B)(6) 2011, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE AT (B)(6). DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED INJURIES TO HER LEFT URETER AND BLADDER. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY SURGERY WITH REPAIR OF THE BLADDER INJURY. THE PATIENT WAS GIVEN TWO UNITS OF PACKED RED BLOOD CELLS DUE TO BLOOD LOSS DURING SURGERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT BEGAN HAVING SEVERE PAIN IN HER BACK AND NOTICED THAT SHE WAS PASSING URINE THROUGH HER VAGINA. SECONDARY TO THIS, THE PATIENT WENT BACK TO THE HOSPITAL AND HAD RADIOLOGY TESTS PERFORMED WHICH, CONFIRMED THAT THE PATIENT HAD A URETERAL INJURY REQUIRING AN IMMEDIATE DIVERSIONARY NEPHROSTOMY TUBE TO BE PLACED BY A RADIOLOGIST. A PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED AND THE STENT WAS ABLE TO PASS FREELY INTO THE BLADDER. THE PATIENT WAS OUTFITTED WITH A NEPHROSTOMY BAG TO COLLECT HER URINE. THE PATIENT WAS THEN TAKEN BACK TO THE OPERATING ROOM AND THE URETERAL STENT IN THE LEFT URETER WAS INTERNALIZED. THIS ALLOWED FOR THE DISCONTINUATION OF THE NEPHROSTOMY BAG. ON (B)(6) 2011, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A CYSTOSCOPY, LEFT URETERAL STENT REMOVAL, BILATERAL URETEROSCOPY, AND RIGHT RETROGRADE PYELOGRAM. DESPITE ALL OF THIS TREATMENT, THE PATIENT HAD RECURRENT DIFFICULTY WITH PELVIC PAIN AND BLADDER FUNCTION AND CONTINUED TO EXPERIENCE INVOLUNTARY LOSS OF URINE THROUGH HER VAGINA. THE PATIENT HAD TO UNDERGO AN ADDITIONAL OPERATION ON (B)(6) 2011, CONSISTING OF CYSTOSCOPY AND FULGURATION OF BLADDER LESION FOR A DIAGNOSIS OF VESICOVAGINAL FISTULA. DESPITE THIS TREATMENT, THE PATIENT CONTINUES TO SUFFER FROM NOCTUREA, PELVIC PAIN, DYSPAREUNIA, AND CONTINUED LEAKAGE OF URINE VAGINALLY." }, { "mdr_text_key": "9850776", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE SITE'S SYSTEM LOG FOUND THAT NO SYSTEM ERROR CODES WERE GENERATED DURING THE SURGICAL PROCEDURE. AT THIS TIME IT IS INDETERMINABLE AS TO WHAT CAUSED DAMAGE TO PATIENT'S URETER AND BLADDER. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE TO THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND TO THE SURGEON. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "10449874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)" } ], "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": "01/10/2013" } ] }