{ "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": "2955842-2010-00140", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20100409", "manufacturer_address_2": "", "pma_pmn_number": "K011002", "date_of_event": "20100310", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20110906", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100409", "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": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS1200 A4.3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20100409", "sequence_number_treatment": [ "DA VINCI SYSTEM INSTRUMENTS, ACCESSORIES AND ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20130122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1655423", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100310", "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": "1645428", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING A DISSECTION, THE MONOPOLAR FOOT PETAL WAS PRESSED, HOWEVER, THE BIPOLAR ENERGY BECAME ACTIVATED. THE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND CREATED A SUPERFICIAL LACERATION TYPE BURN TO THE PATIENT'S BOWEL. A GENERAL SURGEON REVIEWED THE INJURY AND DETERMINED THAT THE BURN WAS NOT THROUGH AND THROUGH AND DID NOT REQUIRE REPAIR, HOWEVER, THE SURGEON PLACED ONE SUTURE IN THE PATIENT'S BOWEL AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND NO FURTHER INSTANCES OF THE EVENT WAS REPORTED." }, { "mdr_text_key": "8540703", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) CONSISTED OF REVIEWING SYSTEM ERROR LOGS AND PERFORMING FUNCTIONAL AND ELECTRICAL TESTS. THE FSE'S REVIEW OF THE LOGS DID NOT REVEAL ANY SYSTEM ERRORS AND THE SYSTEM FUNCTIONED AS INTENDED WITH NO ISSUES. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. AS OF APRIL 8, 2010, THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM WITH NO REPORTED RECURRENCES OF THE REPORTED ISSUE. THE INSTRUMENTS USED IN THE CASE HAVE NOT BEEN RETURNED FOR EVALUATION AS OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED AND / OR IF THE INSTRUMENTS ARE RETURNED AND EVALUATED, A FOLLOW-UP MDR WILL BE SUBMITTED." } ], "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": "01/22/2013" } ] }