{ "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": "2955842-2012-00144", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20120406", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120309", "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": [ "User facility" ], "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": "20120406", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20120406", "sequence_number_treatment": [ "DA VINCI SI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20130108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2521978", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120504", "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": "2530226", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING DA VINCI SI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A BURN LOCATED AT PORT INCISION SITE. INTUITIVE SURGICAL TECHNICAL SERVICE ENGINEER (TSE) PROVIDED THE CUSTOMER WITH POTENTIAL CAUSES THAT MAY CONTRIBUTED TO THE BURNS AT THE PORT INCISION SITE. NO ADDITIONAL PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED." }, { "mdr_text_key": "20167171", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INITIAL MDR WAS INADVERTENTLY SENT WITH INCORRECT INFORMATION: TYPE OF REPORTABLE EVENT." }, { "mdr_text_key": "9896350", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENTS TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARMS TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THIS SITE WITHOUT SUCCESS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "9964947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE AS FUNCTIONAL TESTING OF THE SITE'S DA VINCI SI SYSTEM FOUND THAT THE SYSTEM FUNCTIONED WITHIN SPECIFICATION. THE FSE ALSO TESTED THE SITE'S ELECTRICAL SURGICAL UNIT (ESU) IN CONJUNCTION WITH THE SYSTEM AND IT WAS FOUND TO BE FUNCTIONING NORMALLY. ON (B)(4) 2012 INTUITIVE SURGICAL RECEIVED UF/IMPORTER REPORT NUMBERS (B)(4) AND (B)(4) FROM (B)(6) WITH THE FOLLOWING EVENT DETAILS CONCERNING INSTRUMENTS USED DURING THE SURGICAL PROCEDURE: A THERMAL BURN WAS NOTED AROUND THE TROCAR SITE IN THE PATIENT'S LEFT LOWER ABDOMEN, WHICH WAS SUPERFICIAL. THE INSULATION ON ALL INSTRUMENTS USED WAS CHECKED AND FOUND TO BE INTACT, THIS INCLUDES THE NEEDLE DRIVERS. THE TRIAD DEVICE WAS CHECKED WITH THE GROUND PAD AND FOUND TO BE OPERATING WITHIN NORMAL MANUFACTURER SPECIFICATIONS. ALL ELECTRICAL OUTLETS IN THE ROOM WERE CHECKED AND FUNCTIONING PROPERLY. PER THE SURGEON, THE PORT WAS NOT TOUCHED WITH THE MONOPOLAR DEVICE. ON (B)(4) 2012, INTUITIVE SURGICAL CONTACTED (B)(6) IN THE RISK MANAGEMENT DEPARTMENT AT (B)(6) AND SHE INDICATED THAT UF IMPORTER REPORT NUMBERS (B)(4) AND (B)(4) WERE SUBMITTED TO CAPTURE THE INSTRUMENTS THAT WERE INSTALLED IN THE PATIENT SIDE MANIPULATOR (PSM) ARM OF THE AFFECTED PORT SITE DURING THE SURGICAL PROCEDURE. THE ISSUE OCCURRED WITH ONE PATIENT AND ONE PORT SITE WAS AFFECTED. THE PATIENT SUSTAINED A VERY SUPERFICIAL THERMAL BURN 2MM IN SIZE. THE AFFECTED AREA WAS EXCISED AND NO ADDITIONAL TREATMENT OF THE AFFECTED AREA WAS REQUIRED. THERE WAS NO MALFUNCTION OF THE SITE'S DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND AS OF (B)(6) 2012 THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-OPERATIVE COMPLICATIONS AS A RESULT OF THE BURN. AS OF (B)(6) 2012 THERE HAVE BEEN NO REPORTED RECURRENCES OF THE 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": "05/08/2012;01/08/2013" } ] }