{ "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": "I", "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": "2955842-2020-10338", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20200424", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20181017", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200424", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "461214", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200424", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380652-40", "catalog_number": "N/A", "lot_number": "380652", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00886874110720", "udi_public": "(01)00886874110720", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20200424", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20200328", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9996252", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200328", "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": "193990779", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATION IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ADDITIONALLY, IT IS CONFIRMED THAT ALL THE INSTRUMENTS USED IN THIS PROCEDURE WERE USED IN SUBSEQUENT PROCEDURES. AS OF 21-APR-2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE WAS REPORTEDLY PERFORMED SUCCESSFULLY ON (B)(6) 2018. ALTHOUGH THERE WAS NO INITIAL ALLEGATION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTION, THE PATIENT REPORTED THAT DOCTORS IN (B)(6) 2019 ALLEGED THAT THE PATIENT¿S LYMPH SYSTEM WAS DAMAGED DUE TO A BURN INJURY DURING THE DA VINCI ASSISTED PROCEDURE ON (B)(6) 2018. THERE WAS NO ALLEGATION AND THERE IS NO EVIDENCE THAT AN ISI DEVICE OR ACCESSORY MALFUNCTIONED DURING THE DAVINCI PROCEDURE ON (B)(6) 2018. ADDITIONALLY, IT WAS CONFIRMED THAT ALL THE INSTRUMENTS USED DURING THIS PROCEDURE WERE USED IN SUBSEQUENT PROCEDURES. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD IS UNKNOWN." }, { "mdr_text_key": "193990780", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN A LETTER SEEKING COMPENSATION DIRECTLY FROM INTUITIVE SURGICAL, INC. (ISI), THE PATIENT¿S WIFE REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE PERFORMED ON (B)(6) 2018, THE PATIENT ALLEGEDLY SUSTAINED A BURN INJURY WHICH DAMAGED THE PATIENT'S LYMPH SYSTEM. IN (B)(6) 2013, THE PATIENT HAD AN IVC FILTER IMPLANTED FOR BLOOD CLOTS AT A LOCAL HOSPITAL. IT WAS NOT A COOK FILTER, BUT A RETRIEVABLE FILTER WHICH WAS SUPPOSED TO HAVE BEEN REMOVED IN 6 MONTHS. THE PATIENT ALLEGES HE WAS NOT INFORMED OF THAT, AND THE HOSPITAL DID NOT FOLLOW-UP EITHER. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE AT A DIFFERENT HOSPITAL IN A DIFFERENT TOWN. IMMEDIATELY AFTER SURGERY, FLUID WAS LEAKING FROM THE CENTRAL INCISION AND WAS TREATED WITH A PRESSURE WRAP. AFTER THE PATIENT WAS RELEASED, FLUID CONTINUED TO LEAK FROM THE INCISION BUT THE SURGEON DETERMINED IT WAS NOT FROM THE SURGERY. IN (B)(6) 2018, THE PATIENT HAD ABDOMINAL DISCOMFORT AND WENT TO A LOCAL UROLOGIST. AN ULTRASOUND WAS PERFORMED, AND A LOT OF FLUID WAS IDENTIFIED. THE PATIENT CONTACTED THE ROBOTIC SURGEON; HOWEVER, THE SURGEON¿S RESIDENT RECOMMENDED THE PATIENT GO TO THE ER. THE PATIENT WENT BACK TO THE LOCAL HOSPITAL AND UNDERWENT AN ADDITIONAL ULTRASOUND, AND FOUND THE IVC FILTER THAT HAD BEEN IMPLANTED IN (B)(6) 2013 TO BE CLOGGED. THEN, 6 LITERS OF FLUID WAS REMOVED VIA PARACENTESIS. IN (B)(6) 2019, THE PATIENT WENT TO ANOTHER HOSPITAL IN A DIFFERENT TOWN AND HAD THE IVC FILTER REMOVED. REPORTEDLY, IT HAD PUNCTURED THE PERITONEUM AND AORTA. A VENA CAVA STENT WAS PLACED AND THE HOLES WERE REPAIRED. FOR THE FOLLOWING 6 MONTHS, THE PATIENT HAD LYMPH FLUID REMOVED VIA PARACENTESIS EVERY 2 WEEKS. DOCTORS REPORTED THAT THE PATIENT HAD ASCITES AND A FAILING LIVER; A LIVER BIOPSY WAS REPORTEDLY NORMAL. IN (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT HAD LOST APPROXIMATELY 40 LBS. THE HEPATOLOGIST WHO HAD CONDUCTED THE BIOPSY STATED THE FLUID WAS NOT FROM THE LIVER. IN (B)(6) 2019, THE PATIENT WENT BACK TO SEE THE ROBOTIC SURGEON AND A TEAM OF DOCTORS ATTEMPTED TO REPAIR THE \"DAMAGED LYMPH SYSTEM.\" IT WAS STATED THAT IT WAS \"ACKNOWLEDGED\" THAT THE DAMAGED LYMPH SYSTEM WAS A RESULT OF A BURN INJURY FROM THE ROBOTIC PROSTATECTOMY PROCEDURE ON (B)(6) 2018. THE DOCTORS THEN ATTEMPTED TO ¿SUPER GLUE¿ THE LYMPH SYSTEM; HOWEVER, THEY COULD NOT SUCCEED. AS A RESULT, A DRAIN WAS INSTALLED. THE FOLLOWING WEEK, 500 TO 800 ML OF LYMPH FLUID WAS DRAINED DAILY; HOWEVER, THE DRAIN CAME OUT. ALTHOUGH ATTEMPTS TO REINSTALL THE DRAIN WERE UNSUCCESSFUL, OVER THE NEXT FEW MONTHS, THE FLUID SUBSIDED WITH NO NEED OF A DRAIN OR PARACENTESIS. THE PATIENT¿S CURRENT STATUS IS UNKNOWN." } ], "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": "" } ] }