{ "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": "2955842-2014-04536", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20140728", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140619", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140728", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "438969", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140728", "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 A6.0P8", "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": [ "Leak/Splash", "Fitting Problem", "Device Operates Differently Than Expected" ], "reporter_state_code": "HI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20140728", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20140625", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3958872", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140625", "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": "18134255", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE ANASTOMOTIC LEAK EXPERIENCED BY THE PATIENT. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI REVIEWED THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE AND FOUND A RELATED SYSTEM ERROR CODE 23005 ON AXIS 4 FOR PSM 1. SYSTEM ERROR CODE 23005 IS TRIGGERED WHEN AN EXCESSIVE AMOUNT OF TORQUE WAS COMMANDED TO MOVE THE REPORTED AXIS AND IS CONSISTENT WITH THE OBSERVED BEHAVIOR. DUE TO THE SIGNIFICANT FRICTION, A HIGH AMOUNT OF OUTPUT POWER WAS COMMANDED BY THE SERVO SYSTEM. THERE WERE NO SYSTEM ERRORS GENERATED RELATED TO USAGE OF THE ENDOWRIST STAPLER 45 INSTRUMENT. THE SYSTEM LOGS SHOWED THAT THE INSTRUMENT SUCCESSFULLY FIRED THREE TIMES. THE PSM WAS RETURNED AND EVALUATED. THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE IS3000 SYSTEM. UPON STARTUP, ERROR CODE 23019 AND ERROR CODE 23007 WERE GENERATED FOR AXIS 1 OF THE PSM. THE CLUTCH MOVEMENT WAS ROUGH AND STOPPED AT SPOTS. THE AXIS 1 BRAKE WAS STICKING, WHICH PREVENTED COMPLETION OF A SINE CYCLE TEST DURING A PRE-TEST. THE AXIS 1 BRAKE ALSO FAILED DC VOLTS TESTING AS THE BRAKE DC VOLTAGE WAS OUT OF SPECIFICATIONS. THE AXIS 1 BRAKE AND COMPLETE GEAR SET WERE REPLACED TO REPAIR THE PSM. THE HARMONIC DRIVE WAS REPLACED AS A PRECAUTION. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE PSM FAILED A VISCOUS FRICTION TEST FOR AXIS 2. THE HARMONIC DRIVE WAS REPLACED AS A PRECAUTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI LAR PROCEDURE, THE PATIENT EXPERIENCED AN ANASTOMOTIC LEAK, REQUIRING THE PATIENT TO UNDERGO A SURGICAL PROCEDURE AND COLOSTOMY. IT HAS BEEN DETERMINED THAT THE ARTICULATION ISSUE EXPERIENCED BY THE SITE DID NOT CAUSE OR CONTRIBUTE TO THE ANASTOMOTIC LEAK EXPERIENCED BY THE PATIENT. PER THE INFORMATION PROVIDED, THE SURGEON WAS ABLE TO UTILIZE THE ENDOWRIST STAPLER 45 INSTRUMENT DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE ENDOWRIST STAPLER 45 INSTRUMENT OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "17992163", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI LOW ANTERIOR RESECTION (LAR) PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT PRESENTED SYMPTOMS OF AN ANASTOMOTIC LEAK ON (B)(6) 2014, REQUIRING THE PATIENT TO UNDERGO A SURGICAL PROCEDURE TO REPAIR THE LEAK AND A COLOSTOMY. DURING THE SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEERING (TSE) DUE TO EXPERIENCING ARTICULATION ISSUES WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM 1. THE SITE TOLD THE TSE THAT THEY RESEATED THE STERILE ADAPTER SEVERAL TIMES, BUT DID NOT REPLACE THE DRAPE. THEY ALSO INSTALLED OTHER INSTRUMENTS; HOWEVER THE ISSUE PERSISTED. WITH THE ASSISTANCE OF THE TSE, THE SITE STOWED PSM 1 AND COMPLETED THE PLANNED PROCEDURE USING PSM 2 AND PSM 3. AFTER SOME TIME, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE, CALLED BACK ISI TSE AND REPORTED THAT WHEN SHE CLUTCHED AND MOVED PSM 1, IT BARELY MOVED. ON (B)(6) 2014, A FIELD INVESTIGATION WAS PERFORMED BY THE ISI FIELD SERVICE ENGINEER (FSE). THE FSE WAS ABLE TO REPLICATE THE ISSUE WITH THE PSM EXPERIENCED BY THE SITE. DURING FUNCTIONAL TESTING, AFTER PERFORMING AN EMERGENCY-STOP AND FAULT OVERRIDE, THE YAW AXIS OF THE PSM WAS DIFFICULT TO MOVE. THE FSE REPLACED THE PSM TO REPAIR THE SYSTEM. ON (B)(6) 2014, ISI CONTACTED THE CSR WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, THERE WAS NO MALFUNCTION OF THE ENDOWRIST STAPLER 45 INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE SURGEON WAS ABLE TO FIRE THE INSTRUMENT WITHOUT ANY ISSUES. IT WAS DISCOVERED THAT THE PATIENT HAD A LEAK WHERE THE ENDOWRIST STAPLER 45 INSTRUMENT WAS USED. THE CSR ALSO INDICATED THAT AN UNSPECIFIED NON-ISI ROUND STAPLER WAS USED DURING THE SURGICAL PROCEDURE. NO OTHER INFORMATION WAS PROVIDED." } ], "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": "" } ] }