{ "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": "2955842-2013-03693", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120605", "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": "20130920", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "473268", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130919", "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": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20130919", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Fistula", "Unspecified Infection", "Injury" ] } ], "distributor_city": "", "date_report": "20130930", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358873", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130930", "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": "3931359", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE INJURIES INCLUDING URETER INJURY, URETEROVAGINAL FISTULA, CERVICAL ABSCESSES AND INFECTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME." }, { "mdr_text_key": "11227397", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE INFORMATION RECEIVED 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. INTUITIVE SURGICAL INC. (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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT'S ATTORNEY ALLEGES INJURIES INCLUDING URETER INJURY, URETEROVAGINAL FISTULA, CERVICAL ABSCESSES AND INFECTION AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "23844984", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 09/30/2013, INTUITIVE SURGICAL, INC. WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PATIENT'S DA VINCI HYSTERECTOMY ON (B)(6) 2012 FOR SYMPTOMATIC UTERINE FIBROIDS. ADDITIONAL INFORMATION PROVIDED INCLUDES MODIFIED RECORDS FROM 3 DIFFERENT HOSPITALS WHERE SHE WAS TREATED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF A RECOGNIZED INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH DIFFICULTY BREATHING, FLANK PAIN, AND FEVER AND WAS FOUND TO HAVE RIGHT HYDRONEPHOSIS ON CT SCAN OF THE ABDOMEN. A NEPHROSTOMY TUBE WAS INSERTED INTO THE KIDNEY. ON (B)(6) 2012, A CYSTOSCOPY WAS PERFORMED AND THE PATIENT HAD BLOCKAGE OF THE RIGHT URETER JUST PAST THE RIGHT URETERAL OSTIA. AN X-RAY NEPHROSTOGRAM CONTRAST EXTRAVASATES INTO THE ABDOMEN AND A SECOND NEPHROSTOMY WAS PLACED. URETEROVAGINAL FISTULA DEVELOPED. ON (B)(6) 2012, THE PATIENT UNDERWENT A RIGHT URETERAL REIMPLANTATION. NO FURTHER RECORDS OR CURRENT STATUS WAS PROVIDED. BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. DICTATED OPERATIVE REPORTS SUGGEST THAT BLEEDING PROBLEMS ENCOUNTERED AT THE URETEROVESICAL JUNCTION MADE THE IDENTIFICATION OF THE URETER VERY DIFFICULT AT THIS POINT IN THE PROCEDURE. 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 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": "10/30/2013" } ] }