{ "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": "2955842-2016-00083", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160206", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160108", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "73170", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160206", "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", "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": [ "Misfire" ], "reporter_state_code": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20160206", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20160108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5414780", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160108", "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": "37621634", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE FIELD EVALUATION PERFORMED BY THE TFS, THE PATIENT'S BOWEL INJURY AND THE REPORTED CUSTOMER FAILURE MODE (BIPOLAR AUTO-FIRING) CAN BE ATTRIBUTED TO USER-ERROR. THE TFS CONCLUDED THAT THE BIPOLAR AUTO-FIRING ISSUE WAS CAUSED BY A BIPOLAR INSTRUMENT CORD THAT WAS INCORRECTLY PLUGGED INTO A MONOPOLAR COAG PORT ON THE NON-ISI ESU. THE ALLEGED BIPOLAR AUTO-FIRING ISSUE ALLEGEDLY CAUSED THE REPORTED BOWEL INJURY. THERE IS NO INDICATION THAT AN DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTIONED OR CAUSED/CONTRIBUTED TO THE PATIENT'S BOWEL INJURY. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A BOWEL INJURY THAT WAS OVERSEWN BY THE SURGEON. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USER-ERROR AND THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "37621635", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016, IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, AN UNSPECIFIED BIPOLAR INSTRUMENT AUTO-FIRED AND THE PATIENT SUSTAINED A BURN INJURY TO THE COLON. DETAILS REGARDING THE BURN INJURY WERE NOT INITIALLY PROVIDED. THE INITIAL REPORTER INDICATED THAT THE CORD OF THE BIPOLAR INSTRUMENT WAS CORRECTLY PLUGGED INTO A BIPOLAR PORT ON THE ELECTROSURGICAL UNIT (ESU). ON 01/12/2016, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS DETERMINED THAT THE SURGICAL STAFF HAD ACCIDENTALLY PLUGGED THE BIPOLAR CONNECTORS INTO THE MONOPOLAR COAG PORT ON THEIR NON-ISI ESU. DURING THE FIELD EVALUATION, THE TFS OBSERVED A DA VINCI SURGICAL PROCEDURE AFTER VERIFYING THAT THE BIPOLAR CONNECTORS WERE PLUGGED INTO THE CORRECT PORT ON THE ESU. DURING THE SURGICAL PROCEDURE, THE DA VINCI SURGICAL SYSTEM WORKED APPROPRIATELY. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE SURGICAL STAFF SWITCHED THE BIPOLAR CONNECTORS ON THE ESU TO THE MONOPOLAR PORT. THE SURGICAL STAFF WAS THEN ABLE TO REPLICATE THE AUTO-FIRING ISSUE WITH A BIPOLAR INSTRUMENT. THE SURGICAL STAFF MADE NOTE OF THE ISSUE AND MARKED THE ESU IN AN UNSPECIFIED WAY IN ORDER TO AVOID RECURRENCE OF THE REPORTED BIPOLAR AUTO-FIRING ISSUE. THE TFS INSPECTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(6) 2016, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE CSR VERIFIED THAT THE BIPOLAR AUTO-FIRING ISSUE WAS CAUSED BY A BIPOLAR CORD THAT WAS INADVERTENTLY PLUGGED INTO A MONOPOLAR PORT ON THE ESU. ACCORDING TO THE CSR, THE BOWEL INJURY SUSTAINED BY THE PATIENT WAS OVERSEWN WITH SUTURES BY THE SURGEON. THE CSR DID NOT KNOW THE SEVERITY OF THE BURN. HOWEVER, HE INDICATED THAT THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED POST-OPERATIVE COMPLICATIONS." } ], "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": "" } ] }