{ "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": "", "report_to_fda": "N", "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": "2955842-2010-00266", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20100618", "manufacturer_address_2": "", "pma_pmn_number": "K070684", "date_of_event": "20090918", "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": "20100713", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100618", "brand_name": "DA VINCI 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": "US", "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": "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20100618", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Injury" ] } ], "distributor_city": "", "date_report": "20100519", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1750496", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100519", "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": "1343537", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON MAY 19, 2010, A COPY OF MEDWATCH REPORT # (B)(4) WAS RECEIVED FROM THE FDA, WITH THE FOLLOWING EVENT DESCRIPTION. \"VOLUN 3-APR-2010: MY OBGYN DR (B) (6) PERFORMED A ROBOTIC ASSISTED HYSTERECTOMY. THIS RESULTED IN INJURY TO BOTH URETERS. THE RIGHT URETER HAD TO BE REIMPLANTED, AND THE LEFT URETER WAS STENTED. DR (B) (6) WAS USING A MEDICAL DEVICE CALLED THE 'DA VINCI'. IT WAS SUPPOSED TO BE THE STATE OF THE ART MEDICAL DEVICE IN GYNECOLOGICAL SURGERIES. THE HOSP I WAS IN (B) (6) IN (B) (6). THE HOSPITALS THAT USE THE DA VINCI ARE SUPPOSED TO HAVE A PRIVILEGING OR CREDENTIALING SYSTEM TO DETERMINE THE REQUIREMENTS PRIOR TO PERFORMING ROBOTIC SURGERIES. I DO NOT BELIEVE THAT MY DOCTOR HAD BEEN TRAINED TO USE THIS MEDICAL DEVICE, THAT IS WHY MY INJURIES OCCURRED. ALSO, I HAVE BEEN UNABLE TO GET IN TOUCH WITH ANYONE AT (B) (6) HOSP WHO CAN TELL ME IF THIS PARTICULAR HOSP HAS SET UP A PRIVILEGING SYSTEM IN THE MATTER OF THIS MEDICAL DEVICE. I HAVE NOT BEEN ABLE TO FIND OUT IF THE HOSP HAS FOLLOWED THE REGULATIONS THAT MUST BE FOLLOWED, IN WHICH A REPORT HAS TO BE FILLED OUT WHEN A PT IS INJURED. I WILL CONTINUE TO ASK QUESTIONS FROM THE HOSP ABOUT WHAT AND WHY I WAS INJURED ON (B) (6) 2009.\"" }, { "mdr_text_key": "8635079", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS THE EVENT LOCATION AND PHYSICIAN'S NAME WERE NOT PROVIDED ON VOLUNTARY MEDWATCH REPORT # (B)(4), ISI CONTACTED THE FDA DIVISION OF POSTMARKET SURVEILLANCE ON MAY 20, 2010, TO REQUEST ADDITIONAL INFO REGARDING THIS EVENT. ON MAY 21, 2010, FDA EMPLOYEE (B)(4) INFORMED ISI THAT NO ADDITIONAL INFO COULD BE PROVIDED AND THE INITIAL REPORTER REQUESTED THAT NO FURTHER INFO BE RELEASE. A SEARCH OF OUR COMPLAINT DATABASE WAS PERFORMED AND A PREEXISTING COMPLAINT RECORD COULD NOT BE MATCHED TO THIS EVENT. TO THE BEST OF OUR KNOWLEDGE, THIS EVENT WAS NOT REPORTED TO ISI. THEREFORE, IT IS UNK WHICH DA VINCI SURGICAL SYSTEM AND ASSOCIATED INSTRUMENTS AND ACCESSORIES WERE USED DURING THE TIME OF THE EVENT. AS A RESULT, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED." } ], "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": "" } ] }