{ "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": "2955842-2025-00196", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250108", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20241215", "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": "KS", "manufacturer_contact_area_code": "408", "date_added": "20250108", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240810", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "564363", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250108", "brand_name": "DA VINCI", "generic_name": "INSTRUMENT ARM DRAPE", "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": "430013-15", "catalog_number": "430013", "lot_number": "6324LA0200", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240108", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874113486", "udi_public": "(01)00886874113486(10)6324LA0200", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/08/2025;02/25/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20250108", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241215", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21106192", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241215", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "363032320", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT ARM DRAPE AND PERFORMED FAILURE ANALYSIS EVALUATION. THE INSTRUMENT ARM DRAPE WAS ANALYZED AND FOUND TO HAVE FAILED THE SPIN TEST. THE DRAPE WAS INSTALLED ON AN IN-HOUSE SYSTEM AND COMPLETED THE SETUP. THE SPIN TEST WAS PERFORMED AND FAILED WITH THE OUTER LABYRINTH SPINNING AND AS A RESULT WOULD DISLODGE OFF THE IN-HOUSE SYSTEM. THE ROOT CAUSE IS NOT DETERMINABLE." }, { "mdr_text_key": "363032321", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "360860175", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ARM DRAPE FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE ARM DRAPE HAS NOT BEEN COMPLETED." }, { "mdr_text_key": "360860176", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SP CHOLECYSTECTOMY SURGICAL PROCEDURE, THE RING OF SP DRAPE FELL OUT PREVENTING THE ROTATION WHILE DOCKING. THE PROCEDURE WAS ABORTED POST-ANESTHESIA ADMINISTRATION. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO THE START OF THE PROCEDURE BUT AFTER ANESTHESIA WAS ALREADY ADMINISTERED AND PORTS WERE PLACED. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THERE WERE NO ISSUES WITH THE SYSTEM FUNCTIONALITY. THE CASE WAS ACTUALLY CONVERTED FROM A DA VINCI-ASSISTED SINGLE-PORT CHOLECYSTECTOMY PROCEDURE TO A DA VINCI-ASSISTED MULTIPLE PORT CHOLECYSTECTOMY PROCEDURE. ALSO, A PORT INCISION WAS REPORTEDLY INCREASED IN SIZE. PATIENT INFORMATION WAS NOT AVAILABLE FOR DISCLOSURE." }, { "mdr_text_key": "366722133", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "366722134", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FURTHER FAILURE ANALYSIS (FA) INVESTIGATION WAS PERFORMED, AND INITIAL FA WAS CONFIRMED. FROM THE INITIAL FA, THE DRAPE EXHIBITED SEIZING AND FAILED THE SPIN TEST WHICH DEMONSTRATED THE DRAPE'S INABILITY TO ALLOW FOR FULL ROTATION OF THE INSTRUMENT DRIVES. INVESTIGATIONS BY ENGINEERING OF DRAPES EXHIBITING THIS FAILURE MODE FOUND THAT THE OUTER LABYRINTH'S \"CONTROL PAD HEIGHT\" TO BE OUT OF SPECIFICATION WHICH CREATES MATING ISSUES BETWEEN THE OUTER AND INNER LABYRINTH, LEADING TO EXCESS FRICTION OR SEIZING RESULTING IN DETACHMENT FROM THE SYSTEM WHEN ATTEMPTING TO ROTATE A DRAPED SYSTEM'S INSTRUMENT DRIVES. THE CONTROL PAD HEIGHT IS SPECIFICALLY THE DISTANCE ON THE OUTER LABYRINTH BETWEEN THE LIP AND TRAPEZOIDAL FEATURE THAT HOLDS THE INNER LABYRINTH WITHIN THE OUTER LABYRINTH. THE OUT OF SPECIFICATION CONDITION WAS CONFIRMED BY TESTING THE DRAPE'S OUTER LABYRINTH'S CONTROL PAD HEIGHTS WITH A 0.316\" GAGE BLOCK, WHICH REPRESENTS THE LOWER SPECIFIED LIMIT OF THE CONTROL PAD HEIGHT. ALL 12 OF THE CONTROL PAD HEIGHTS WERE FOUND TO FAIL THE GAGE BLOCK TEST, INDICATING THAT ALL 12 CONTROL PAD HEIGHTS ARE OUT OF SPECIFICATION AND ARE LESS THAN THE LOWER SPECIFIED LIMIT." } ], "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": "02/05/2025;03/24/2025" } ] }