{ "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": "2955842-2026-02287", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260205", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260108", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260205", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201124", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "328289", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260205", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260121", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "No Device Output" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/22/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260601", "health_professional": "Y", "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": "20260205", "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" ] } ], "distributor_city": "", "date_report": "20260514", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24267262", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260108", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "401690587", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FURTHER INVESTIGATION WAS PERFORMED. THE FSE COMPLETED THE LINE PARTS USED (LPU) FOR THE REMAINING TWO PATIENT SIDE MANIPULATORS (PSM'S) AND ADDITIONAL FINDINGS WERE NOTED. THE PATIENT SIDE MANIPULATORS (PSM) 2 AND 3 HAVE BEEN RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. DURING VISUAL INSPECTION OF PSM 3, THE INSERTION BELT WAS SEEN BROKEN AT THE DISTAL END AND A PIECE OF THE BELT WAS HANGING OUT OF THE INSERTION AXIS. THE BELT WAS REPAIRED AND INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT HAD FUNCTIONED AS DESIGNED. THE UNIT WAS THEN INSTALLED ONTO A TEST PLATFORM AND PASSED ALL TESTING WITHIN SPECIFICATION. DURING VISUAL INSPECTION OF PSM 2, NO ISSUES WERE SEEN THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE WHEN FIRST EXERCISING THE INSERTION AXIS, MINOR RESISTANCE WAS FELT WHEN EXTENDING. AFTER RETRACTING THE INSERTION AND EXTENDING ONCE AGAIN, THE INSERTION BELT HAD SNAPPED, AND RESISTANCE COULD NO LONGER BE FELT. THE BELT WAS REPAIRED AND INSTALLED BACK ONTO THE SYSTEM WHERE THE PSM HAD THEN FUNCTIONED AS DESIGNED. THE UNIT WAS INSTALLED ONTO A TEST PLATFORM AND PASSED ALL TESTING WITHIN SPECIFICATION. THE MINOR FRICTION AND BROKEN BELT WILL BE CONSIDERED REPLICATION OF THE REPORTED PROBLEM." }, { "mdr_text_key": "401690588", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "392173623", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN TONGUE BASE RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THERE WERE ISSUES MANIPULATING THE PATIENT SIDE MANIPULATOR (PSM) ARMS. THE PSM WAS NOT RESPONDING. THE PSM WAS DISCONNECTED. THE TSE ATTEMPTED TO REVIEW THE LOGS BUT WAS NOT ABLE TO. THE VIEW OF EVENTS SHOWED PSM 1 WAS NOT IN USE. THE CUSTOMER TRIED REBOOTING WITH NO CHANGE AND DID NOT WANT TO TROUBLE SHOOT FURTHER AT THE TIME. THE CUSTOMER CALLED LATER TO REPORT THE SURGEON WAS HAVING ISSUES MANIPULATING THE ARMS TO THE POINT THEY DECIDED TO CONVERT, AND THE TSE REVIEWED THE LOGS BUT FOUND NO RELATED ISSUE. THE CUSTOMER POWER CYCLED THE SYSTEM, RESEATED THE DRAPES AND REINSTALLED THE INSTRUMENTS; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER CALLED BACK STATING THAT THE INSTRUMENT OUT OF PSM ARMS 2 AND 3, THERE'S A PHYSICAL RESISTANCE THAT'S BINDING IT, MAKING IT DIFFICULT TO RETRACT; HOWEVER, INSERTING INSTRUMENTS WAS WORKING FINE. THE NURSE STATED THAT ALL 4 PSM ARMS WERE HAVING RESISTANCE. THEY TRIED ANOTHER INSTRUMENT, RE-DRAPING, AND REBOOTING TO NO RESOLVE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY." }, { "mdr_text_key": "392173624", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON SITE AND THE SYSTEM BOOTED UP AND ALL ARMS WERE TESTED VARIOUS AMOUNTS OF TIMES AND IN VARIOUS POSITIONS AND FOLLOW MODE WAS PERFORMED AS EXPECTED WITH NO ERRORS OR ISSUES. THE FSE PERFORMED CALIBRATION AND ALL TESTS PASSED. THERE WERE NO ERRORS IN THE LOGS. THE FSE WAS UNABLE TO REPLICATE THE ISSUE AND SUSPECTED IT WAS SETUP RELATED; HOWEVER, THE FSE DID REPLACE TWO PATIENT SIDE MANIPULATORS (PSMS) TO RESOLVE THE ISSUE FOR THE CUSTOMER. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ISSUE WAS NOT CONFIRMED OR REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNITS WERE INSTALLED ONTO A GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. AFTER OPERATING AND MOVING TO ALL LIMITS REPETITIVELY, NO RESISTANCE OR ABNORMAL FEEDBACK COULD BE FOUND WITH EXTENSIVE MOVEMENT TESTING. THE UNITS WERE THEN INSTALLED ONTO A TEST PLATFORM AND PASSED ALL RELEVANT TESTING WITHIN SPECIFICATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/14/2026" } ] }