{ "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": "2955842-2012-00184", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120429", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120328", "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": [ "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120801", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120429", "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": "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20120429", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2552349", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120328", "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": "2688854", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI GASTRIC BYPASS PROCEDURE THE SURGEON WAS UNABLE TO MOVE PATIENT SIDE MANIPULATOR (PSM) ARM 2 FROM THE SURGEON CONSOLE. AFTER RESTARTING THE SYSTEM, PSM ARM 2 WORKED FINE. AFTER 15 MINUTES OF OPERATION THE SURGEON LOST CONTROL OF PSM ARM 1, RESULTING IN DAMAGE TO THE PATIENT'S STOMACH. NO FURTHER INJURIES WERE REPORTED." }, { "mdr_text_key": "10450337", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "9967079", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYSTEM LOGS WERE REVIEWED BY AN ISI TECHNICAL SUPPORT ENGINEER AND NO ERRORS WERE OBSERVED WHICH INDICATE THAT THERE WERE ISSUES WITH THE PSM ARMS. THE PSMS ARE INSTRUMENT ARMS LOCATED ON THE PATIENT CART THAT PROVIDE THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE ROOT CAUSE OF THE SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT IS CURRENTLY UNDETERMINED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN ADDITIONAL INFORMATION ABOUT THE EVENT, BUT THE CUSTOMER HAS YET TO PROVIDE FURTHER DETAILS. IF ADDITIONAL EVENT DETAILS BECOME AVAILABLE A FOLLOW UP MDV 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": "01/10/2013" } ] }