{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Death", "report_number": "2955842-2022-10269", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220218", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220218", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190927", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "16984", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220218", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220124", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13555350", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "285799679", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, A THIRD PARTY STAPLER INSTRUMENT WAS USED ON UNSPECIFIED TISSUE. THE STAPLE LINE REPORTEDLY DID NOT HOLD AND CAUSED THE PATIENT TO BLEED TO DEATH. AT THIS TIME, THERE ARE NO KNOWN ALLEGATIONS AGAINST A DA VINCI PRODUCT. ON 28-JAN-2022, AN INTUITIVE SURGICAL INC. (ISI) ENTERPRISE SOLUTION MANAGER (ESM) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ESM WAS MADE AWARE OF THIS EVENT FROM THE SITE ROBOTICS COORDINATOR. THE CUSTOMER SITE HAS NOT PROVIDED ANY ADDITIONAL INFORMATION AT THIS TIME AS THE EVENT IS BEING REVIEWED BY THEIR RISK MANAGEMENT DEPARTMENT. IT IS UNKNOWN WHAT BRAND THIRD PARTY STAPLER WAS USED AND ON WHAT BLOOD VESSEL. THE THIRD PARTY STAPLE LINE REPORTEDLY BLED DURING THE PROCEDURE. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING AND THEN TO RESUSCITATE THE PATIENT; BUT THE PATIENT EXPIRED. IT WAS REPORTED THAT THE VESSEL THAT WAS STAPLED AND BLED WAS VERY CALCIFIED. THE SURGEON REPORTEDLY CUT MULTIPLE CABLES AT THE PATIENT BEDSIDE TO REMOVE THEM FROM THE FIELD. IT WAS REPORTED THAT THE DA VINCI SP CAMERA CABLE WAS CUT DURING THIS EVENT. ON 15-FEB-2022, ISI CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE SURGEON REPORTED: \"PLEASE NOTE THAT THE ROBOTIC PLATFORM HAD NOTHING TO WITH THE ADVERSE OUTCOME. WHEN THE PATIENT CODED, SCISSORS WERE USED TO CUT AWAY THE DRAPES FROM THE PATIENT TO PERFORM CPR AND THE CAMERA CABLE WAS ACCIDENTALLY CUT.\" NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "285799680", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS FOR THE PROCEDURE DATE OF (B)(6) 2022 HAS BEEN PERFORMED BY AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING WAS OBSERVED: MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AFTER THIS REPORTED COMPLAINT WITH NO FURTHER COMPLAINTS BEING CREATED. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AS A RESULT OF THIS REVIEW, THE TSE DID NOT RECOMMEND AN ISI FIELD SERVICE ENGINEER (FSE) VISIT THE SITE TO PERFORM SYSTEM VERIFICATION TESTING. THE CUSTOMER HAS NOT CREATED AND SERVICE REQUESTS SINCE THIS REPORTED EVENT. ALL MULTI-USE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THE SINGLE-USE INSTRUMENTS AND THE SP CAMERA WHICH HAD ITS CABLE CUT BY THE SURGEON MAKING IT INOPERABLE. NO ADDITIONAL COMPLAINTS HAVE BEEN MADE AGAINST ANY OF THE INSTRUMENTS USED DURING THIS PROCEDURE. A MEDICAL REVIEW OF THE EVENT INFORMATION WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING INFORMATION WAS PROVIDED: THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENTS SEEMS TO INDICATE THAT THE PATIENT EXPERIENCE UNCONTROLLED BLEEDING THAT OCCURRED AFTER ATTEMPTING TO TRANSECT A BLOOD VESSEL USING A THIRD-PARTY STAPLER. THERE IS NO INFORMATION PROVIDED AS TO THE MANUFACTURER OF THE THIRD-PARTY STAPLER. ADDITIONALLY, IT IS UNKNOWN AS TO WHAT STAPLER CARTRIDGE WAS SELECTED DURING THE ATTEMPTED VESSEL TRANSECTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING FROM A STAPLE LINE CREATED WITH THE USE OF A THIRD-PARTY STAPLER INSTRUMENT. ATTEMPTS TO CONTROL THE BLEEDING AND SUBSEQUENTLY RESUSCITATE THE PATIENT WERE UNSUCCESSFUL. THE PATIENT EXPIRED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }