{ "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": "2955842-2013-03281", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130829", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20111212", "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": "20130830", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "426498", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130829", "brand_name": "DA VINCI 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": "", "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": "20250819", "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": "20130829", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "34 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence", "Pain" ] } ], "distributor_city": "", "date_report": "20120805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3317784", "removal_correction_number": "", "number_devices_in_event": "", "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": "3952975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING OPERATIVE REPORT OF A PATIENT WHO UNDERWENT A DA VINCI LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2011. THIS LEGAL ALLEGATION INDICATES THAT THE PATIENT SUFFERED POST-OPERATIVE COMPLICATIONS AFTER A DA VINCI HYSTERECTOMY PROCEDURE. THE PATIENT UNDERWENT A DA VINCI PROCEDURE ON (B)(6) 2011 AND IT WAS NOTED IN THE OPERATIVE REPORT THAT THE PROCEDURE WAS UNEVENTFUL. THE PATIENT EXPERIENCED PAIN DURING POSTOPERATIVE COURSE WHICH WAS WELL CONTROLLED BY POST-OPERATIVE DAY 2. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 (TWO DAYS AFTER SURGERY) IN A STABLE CONDITION. THERE IS NO INDICATION THAT THE DA VINCI SYSTEM, INSTRUMENT OR ACCESSORIES MALFUNCTIONED BASED ON THE OPERATIVE REPORT. AS PER THE MEDICAL RECORDS, THE PATIENT DEVELOPED LEFT LOWER QUADRANT AND LEFT FLANK PAIN, VAGINAL LEAKAGE AND URINARY INCONTINENCE TWO WEEKS POST-OPERATIVELY AND WAS ADMITTED AND EVALUATED ON (B)(6) 2011. A CT UROGRAM ON (B)(6) 2011 SHOWED A LEFT DISTAL URETERAL INJURY AND A URETEROVAGINAL FISTULA. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2012 FOR FURTHER EVALUATION AND A CYSTOSCOPY SHOWED NO EVIDENCE OF VESICOVAGINAL FISTULA AND RIGHT RETROGRADE PYELOGRAM WAS NORMAL. THE LEFT PYELOGRAM INDICATED A LEFT URETEROVAGINAL FISTULA. ATTEMPTED STENT PLACEMENT WAS UNSUCCESSFUL AND THE PATIENT WAS PLACED WITH A LEFT PERCUTANEOUS NEPHROSTOMY TUBE FOR PERCUTANEOUS DRAINAGE. THIS PATIENT WAS EVALUATED AT A PLANNED 3 MONTH FOLLOW UP (ON (B)(6) 2012) FOR A FURTHER DIAGNOSTIC EVALUATION. THERE WAS NO EVIDENCE OF VESICOVAGINAL FISTULA ON CYSTOGRAM. BASED ON THE OPERATIVE FINDINGS THE DISTAL LEFT URETERAL STRICTURE WAS DEEMED APPROPRIATE FOR URETERAL REIMPLANTATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO A RECOVERY ROOM IN STABLE CONDITION WITH NO NOTED COMPLICATIONS. NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED ABOUT THE PATIENT'S CURRENT CONDITION." }, { "mdr_text_key": "11134985", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION THAT WAS PROVIDED TO INTUITIVE SURGICAL DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THIS LEGAL COMPLAINT ALLEGES THAT THE PATIENT SUFFERED POST-OPERATIVE COMPLICATIONS AFTER A DA VINCI LAPAROSCOPIC 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": "" } ] }