{ "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": "2955842-2016-00022", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20160108", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "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": "20160108", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "14680", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160108", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL INSTRUMENT", "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": "IS4000", "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": [ "Positioning Problem", "Torn Material" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "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": "20160108", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Rupture", "Hemorrhage/Blood Loss/Bleeding", "Rupture" ] } ], "distributor_city": "", "date_report": "20151211", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5355670", "removal_correction_number": "", "number_devices_in_event": "", "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": "35531833", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY INVOLVED WITH THIS REPORTED EVENT HAVE NOT BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE, BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY OF THE POTENTIALLY RELATED DEVICES ARE RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON CLAIMED THAT A VESSEL BURST AND REQUIRED REPAIR AFTER UNINTENTIONAL ENERGY WAS TRANSMITTED TO THE VESSEL DURING USE OF THE MCS WITH THE ERBE GENERATOR. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. ALSO, THERE IS NO INDICATION FROM THE VIDEO PROVIDED THAT A MALFUNCTION OF AN ISI DEVICE OCCURRED." }, { "mdr_text_key": "35531834", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) AND A VESSEL IN CLOSE PROXIMITY TO THE INSTRUMENT QUICKLY BLANCHED AND THEN BURST. THE SURGEON PROVIDED INTUITIVE SURGICAL, INC. (ISI) WITH A VIDEO CLIP OF THE REPORTED EVENT. DURING THE VIDEO, A VESSEL TOWARDS THE BACK END OF AN MCS INSTRUMENT BLANCHED QUICKLY FROM PALE WHITE TO BRIGHT WHITE IN COLOR AND THEN BURST. THE VIDEO REVEALS THAT WHILE ENERGY WAS BEING APPLIED, THE BLADES OF THE MCS INSTRUMENT WERE RESTING AGAINST THE VESSEL THAT WAS EVENTUALLY DAMAGED. THE VIDEO CLIP ALSO REVEALED THAT THE MCS TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT WAS TORN AT THE MOUTH OF THE ACCESSORY. HOWEVER, THERE IS NO INDICATION THAT THE ACCESSORY DAMAGE CAUSED OR CONTRIBUTED TO THE VESSEL INJURY. THE SURGEON CLAIMED THAT THIS EVENT MIGHT NOT HAVE OCCURRED IF HE HAD BEEN USING DIFFERENT ENERGY MODALITIES AND SETTINGS. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING REGARDING THE REPORTED EVENT: THE EVENT OCCURRED DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE THAT HE PERFORMED ON AN UNSPECIFIED DATE. THE VESSEL THAT BURST WAS THE RIGHT RENAL VEIN. THE SURGEON BELIEVES THE VESSEL BURST AS A RESULT OF TRANSMITTED ENERGY FROM MONOPOLAR CAUTERY TO RENAL VEIN. THE SURGEON INDICATED THAT HE WAS ABLE TO CONTROL THE BLEEDING AND REPAIRED THE VESSEL VIA SUTURE LIGATION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS APPROXIMATELY 150 CC. THE PATIENT DID NOT RECEIVE ANY BLOOD TRANSFUSIONS. IN ADDITION, THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE SURGEON, THE PATIENT WAS RECOVERING WELL. THE SURGEON WAS USING THE DA VINCI XI SURGICAL SYSTEM WITH 6, 6, 6 GENERATOR SETTINGS. HE DID NOT KNOW IF THE MCS INSTRUMENT WAS AVAILABLE FOR RETURN TO ISI FOR EVALUATION." } ], "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": "" } ] }