{ "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": "Injury", "report_number": "2955842-2024-18797", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240903", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20240806", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20240903", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230504", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1105022", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240903", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE", "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": "470056-11", "catalog_number": "470056", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240821", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874116562", "udi_public": "(01)00886874116562", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Display or Visual Feedback Problem", "Display or Visual Feedback Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/05/2024;10/09/2024;04/01/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20240903", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "56 YR", "patient_sex": "Male", "patient_weight": "94 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels", "Great Vessel Perforation", "Stenosis", "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels", "Great Vessel Perforation", "Stenosis" ] } ], "distributor_city": "", "date_report": "20240806", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20126755", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240806", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "350794020", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, THE IMAGE OF THE SURGICAL FIELD FROZE TWICE WHILE THE SURGEON WAS DISSECTING THE ILIAC ARTERY, CAUSING AN INJURY AND BLEEDING. THE 0 DEGREE ENDOSCOPE PLUS WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY IDENTIFIED. WHEN THE IMAGE FROZE FOR APPROXIMATELY 1 MINUTE, THE SYSTEM WAS STILL DISPLAYING THE SURGICAL FIELD, BUT THE IMAGE DID NOT REACT TO THE MOVEMENT INITIATED BY THE SURGEON. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BEING USED TO DISSECT THE ILIAC ARTERY WHEN THE LOSS OF THE IMAGE OCCURRED; CAUSING THE MCS INSTRUMENT TO INJURE THE ARTERY AND BLEEDING OCCURRED. THE BLEEDING WAS UNEXPECTED, AND THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 400ML. TO RESOLVE THE BLEEDING, THE HOLE ON THE ARTERY WAS SUTURED CLOSED; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE, AND UPON REVIEWING THE LOGS, A RECURRENT ERROR INDICATING AN ISSUE WITH THE 0 DEGREE ENDOSCOPE PLUS WAS OBSERVED. THE CUSTOMER INFORMED THE TSE THAT A SPARE 0 DEGREE ENDOSCOPE PLUS WAS NOT AVAILABLE IN ORDER TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY, BY RESTARTING THE 0 DEGREE ENDOSCOPE PLUS. POST-OPERATIVELY, THE PATIENT EXPERIENCED NARROWING OF THE ILIAC ARTERY AND VASCULAR STENTING WAS PERFORMED THE NEXT DAY. THE PATIENT IS CURRENTLY WELL AND HAS SINCE BEEN DISCHARGED." }, { "mdr_text_key": "350794021", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE 0 DEGREE ENDOSCOPE PLUS THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND REVEALED POSSIBLE RELATED SYSTEM ERRORS: LOSS OF LEFT ENDOSCOPE VIDEO TO ENDOSCOPE CONTROLLER (EC) / RESEAT SCOPE CONNECTION (POSSIBLE SCOPE OR EC)." }, { "mdr_text_key": "368956178", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: ADDITIONAL INVESTIGATION WAS PERFORMED TO REVIEW THE RETRACTED INSULATION AND FOUND THAT WHEN THE CONDUCTOR WIRE BROKE INSIDE THE YAW PULLEY, THE SAME FORCE CONTRIBUTED TO THE INSULATION BECOMING RETRACTED." }, { "mdr_text_key": "355549112", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA) WAS ABLE TO CONFIRM AND REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE WITHIN THE BIPOLAR YAW PULLEY, BETWEEN THE WIRE CRIMP ON THE GRIP AND THE SILICONE POTTING, WHICH SEALS THE WIRE ENTRANCE TO THE YAW PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. COMPONENTS ADJACENT TO THE BROKEN WIRE DID NOT SHOW DAMAGE. ADDITIONALLY, THE CONDUCTOR WIRE HAD A RETRACTED INSULATION; COMPONENTS ADJACENT TO THIS WIRE DID NOT SHOW DAMAGE." }, { "mdr_text_key": "355549113", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "353143943", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "353143944", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE ENDOSCOPE PLUS 0 DEGREE CAMERA TO PERFORM FAILURE ANALYSIS (FA) CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE ENDOSCOPE WAS PLUGGED ON THE IN-HOUSE SYSTEM OR EQUIVALENT AND PROVIDED COLOR BARS IN FOR CAMERA INSTRUMENT - LOSS OF VISION. ADDITIONALLY, THE ENDOSCOPE WAS VISUALLY INSPECTED AND PLACED ON THE IN-HOUSE SYSTEM AND DETECTED WITH A CAMERA MODULE ISSUE. THE CAMERA MODULE EXHIBITED AN OPTICAL COMPONENT DAMAGED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE DVSTREAM LOG AND KINEMATIC DATA FOR SYSTEM ID (B)(6) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED AND A REVIEW OF THE DATA SHOWED THERE WERE LEFT EYE VIDEO LOSS RELATED ERRORS STARTING AT THE BEGINNING OF THE PROCEDURE. THE SURGEON RECOVERED FROM THESE ERRORS MULTIPLE TIMES AND CONTINUED WITH THE SAME ENDOSCOPE. THE RECOMMENDATION IS TO HAVE A BACKUP ENDOSCOPE AVAILABLE AND TO SWAP ENDOSCOPES IF ISSUES ARISE. A REVIEW OF THE LOGS FOR THE ENDOSCOPE SHOWED THAT IT WAS LAST USED ON (B)(6) 2024 (THE DATE OF THE EVENT) ON (B)(6). THE FAILURE ANALYSIS RESULTS DID CONFIRM AND REPLICATE VIDEO LOSS ISSUES. WHEN PLACED ON AN IN-HOUSE SYSTEM THE ENDOSCOPE FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL COMMUNICATION FAILURE. ADDITIONAL OBSERVATION DURING INSPECTION WAS A CAMERA MODULE ISSUE WHICH CAN HAPPEN FROM INADVERTENT COLLISIONS WITH HARD SURFACES OR DROP OF THE SCOPE. IN SECTION 10.4 SURGICAL CONTROLS OF THE DA VINCI X SYSTEM USER MANUAL (554021-08) THE FOLLOWING WARNING IS WRITTEN: WARNING: DO NOT MOVE INSTRUMENTS IF THE TIPS ARE NOT VISIBLE IN THE 3D VIEWER. FAILURE TO OBSERVE THIS WARNING CAN CAUSE SERIOUS HARM TO THE PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/26/2024;10/29/2024;04/25/2025" } ] }