{ "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": "2955842-2013-00063", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130107", "manufacturer_address_2": "", "pma_pmn_number": "K060391", "date_of_event": "20121206", "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": "20130107", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "7940", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130107", "brand_name": "DA VINCI S 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": "IS2000 A5.P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "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": [ "Charred" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130107", "sequence_number_treatment": [ "DAV S SURG SYS, MCS INSTRMNT, MCS TIP CVR, ESU" ], "sequence_number_outcome": [ "" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20121206", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2898303", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121206", "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": "3103358", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT WHILE UNDOCKING AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED CHARRING AT ONE OF THE PORT INCISION SITES. THE SURGEON EXCISED A SMALL AREA OF THE AFFECTED PORT SITE, SUTURE CLOSED THE INCISION AND APPLIED A DRY DRESSING. THE EXCISED SAMPLE WAS SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT TO BE ANALYZED. THE ROBOTICS COORDINATOR PRESENT DURING THE SURGICAL PROCEDURE INDICATED THAT THERE WAS NO HARM TO THE PATIENT DURING THE SURGICAL PROCEDURE AND THE SYSTEM DID NOT FAULT DURING THE PLANNED SURGICAL PROCEDURE." }, { "mdr_text_key": "10464599", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE SITE'S DA VINCI S SURGICAL SYSTEM FOUND THAT THE SYSTEM FUNCTIONED WITHIN SPECIFICATION AND THE SYSTEM ALSO PASSED AN ELECTRICAL SAFETY TEST. ON (B)(4) 2012, ISI CONTACTED (B)(6) AT (B)(6). (B)(6) INDICATED THAT AN MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS USED IN THE PATIENT SIDE MANIPULATOR OF THE AFFECTED PORT SITE. (B)(6) INDICATED THAT A VALLEY LAB FORCE FX ELECTRICAL SURGICAL UNIT (ESU) WAS USED DURING THE SURGICAL PROCEDURE AND THE SETTING WAS 30 COAG. (B)(6) INDICATED THAT THE CANNULA AND MCS INSTRUMENT WERE INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE NOTED. (B)(6) INDICATED THAT ARCING DURING THE SURGICAL PROCEDURE WAS NOT OBSERVED. (B)(6) INDICATED THAT THE GROUND PAD WAS POSITIONED ON THE PATIENT'S LEFT ANTERIOR THIGH AND INSPECTION OF THE GROUNDING PAD WAS INSPECTED AND THERE WERE NO ISSUES FOUND. ON (B)(6) 2012, ISI RECEIVED AN EMAIL RESPONSE FROM (B)(6). (B)(6) INDICATED THAT THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE INDICATED TO HIM THAT THE PATHOLOGY REPORT CONFIRMED THAT THE PATIENT SUSTAINED A THERMAL BURN AT THE PORT SITE. PER (B)(6), THE SURGEON INDICATED THAT THE PATIENT IS HEALING FINE AND WITHOUT INCIDENT. (B)(6) INDICATED THAT IT IS THE SURGEON'S BELIEF THAT THE THERMAL BURN SUSTAINED BY THE PATIENT WAS CAUSED BY A LEAK OF ELECTRICAL CURRENT FROM THE MCS INSTRUMENT AS IT WAS BEING ACTIVATED FROM THE SURGEON SIDE CONSOLE DURING ROUTINE TISSUE CAUTERIZATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE RETURNED TO ISI FOR EVALUATION. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED ISSUE. THE MCS INSTRUMENT EXHIBITED SLIGHT CHAR MARKS AT THE SCISSOR TIPS; HOWEVER, NO ARCING DAMAGE TO THE TUBE EXTENSION NOR ON THE CLEVIS WAS FOUND. THE TIP COVER ACCESSORY USED IN CONJUNCTION WITH THE MCS INSTRUMENT EXHIBITED NO PHYSICAL DAMAGE. THE MCS INSTRUMENT FAILED CUT TESTING. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS ISSUE AT THIS HOSPITAL." } ], "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": "" } ] }