{ "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": "2955842-2012-00442", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20120914", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120822", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120917", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120914", "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 A6.0P6", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "20120914", "sequence_number_treatment": [ "DAVINCI SI SYSTEMS INSTRUMENT AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "39 YR", "patient_sex": "", "patient_weight": "87", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20130108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2746251", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120822", "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": "2877219", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, A BOWEL LACERATION OCCURRED; THE LACERATION WAS REPAIRED." }, { "mdr_text_key": "10176345", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, (B)(6), THE ROBOTICS COORDINATOR AT (B)(6) MEDICAL CENTER. HE INDICATED THAT A 'LITTLE NICK/CUT' WAS MADE ON THE PATIENT'S BOWEL TOWARDS THE END OF THE PROCEDURE. THE AFFECTED AREA WAS REPAIRED WITH A STITCH SUTURE. THE PATIENT DIDN'T SUFFER ANY OTHER INJURIES RELATED WITH THIS INCIDENT. HE INDICATED THAT HE DID NOT RECALL RECEIVING ANY SYSTEM ERROR CODES DURING THE PROCEDURE. THE PATIENT WAS POSITIONED IN THE DORSAL LITHOTOMY POSITION. AN INTUITIVE SURGICAL FIELD SERVICE ENGINEER (FSE) HAD BEEN CONTACTED TO VISIT THE ACCOUNT TO INSPECT THE DAVINCI SYSTEM. A FOLLOW-UP MDR WILL BE SUBMITTED IF A DEVICE IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. AS OF THE DATE OF THIS REPORT, THE CUSTOMER HAS CONTINUED USING THE DAVINCI SI ROBOT SYSTEM WITH NO ISSUES." } ], "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": "01/08/2013" } ] }