{ "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": "I", "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": "2955842-2017-00372", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20170616", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20170516", "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", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20170616", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "428500", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170616", "brand_name": "DA VINCI XI 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": "SK0141 A70P5D", "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": [ "Device Issue", "Device Issue" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20170616", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20170608", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6646738", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170608", "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": "77740739", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE REPORTED CUSTOMER FAILURE MODE. IT IS UNKNOWN IF THE DA VINCI SURGICAL SYSTEM WAS IN A FAULT STATE WHEN THE EVENT OCCURRED AND WHY THE SURGICAL STAFF DID NOT ATTEMPT TO USE AN INSTRUMENT GRIP RELEASE TOOL. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, AN UNSPECIFIED INSTRUMENT BECAME UNRESPONSIVE ON ARM 3. IN ORDER TO REMOVE THE INSTRUMENT, THE SURGEON DISSECTED FATTY TISSUE THAT WAS STUCK BETWEEN THE GRIPS OF THE INSTRUMENT. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN." }, { "mdr_text_key": "77740740", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, AN UNSPECIFIED INSTRUMENT INSTALLED ON ARM 3 STOPPED RESPONDING. AT THAT TIME, THE UNSPECIFIED INSTRUMENT WAS GRASPING FATTY TISSUE. IN ORDER TO REMOVE THE INSTRUMENT, THE SURGEON MADE THE DECISION TO DISSECT THE GRASPED TISSUE. WHEN THE EVENT OCCURRED, THE SURGICAL STAFF REPORTEDLY DID NOT ATTEMPT TO USE AN INSTRUMENT GRIP RELEASE TOOL. ACCORDING TO THE DA VINCI SI USER MANUAL, THE EMERGENCY GRIP RELEASE MECHANISM FACILITATES REMOVAL OF AN INSTRUMENT IN THE EVENT OF A SYSTEM FAULT. FOR EXAMPLE, IF THE INSTRUMENT TIPS ARE HOLDING TISSUE, THE EMERGENCY GRIP RELEASE ALLOWS THE PATIENT SIDE OPERATOR TO MANUALLY RELEASE THE GRIP. THE DA VINCI INSTRUMENT AND ACCESSORIES USER MANUAL STATES THE FOLLOWING GENERAL PRECAUTIONS AND WARNINGS: WARNING: DO NOT PERFORM GRIP RELEASE ON A NON-FAULTED SYSTEM WITHOUT FIRST PRESSING THE EMERGENCY STOP BUTTON. FAILURE TO OBSERVE THIS WARNING MAY RESULT IN UNINTENDED INSTRUMENT MOTION OR DAMAGE TO THE GRIP RELEASE MECHANISM. WARNING: IN CASE OF SYSTEM FAILURE WHILE THESE INSTRUMENTS ARE GRASPING TISSUE, THE GRIPS CAN BE MANUALLY OPENED BY INSERTING THE GRIP RELEASE TOOL INTO THE GRIP RELEASE HOLE IN THE INSTRUMENT HOUSING AND CAREFULLY TURNING. SQUEEZE THE RELEASE LEVERS AND WITHDRAW THE INSTRUMENT. USE VISUALIZATION OF SURGICAL SITE WHEN INSERTING THE GRIP RELEASE TOOL, OPENING JAWS, CLEARING JAWS FROM TISSUE, AND REMOVING THE INSTRUMENT FROM THE SYSTEM. ACCORDING TO THE INITIAL REPORTER, THE UNSPECIFIED INSTRUMENT WAS ULTIMATELY REMOVED FROM ARM 3 AND TESTED ON ARM 2. THE INSTRUMENT REPORTEDLY WORKED ON ARM 2. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }