{ "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": "2955842-2026-15404", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20260311", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20260312", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240830", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "636527", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260311", "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": "380601-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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": [ "Key or Button Unresponsive/not Working" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/13/2026;03/20/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260618", "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": "20260311", "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": "20260408", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24573572", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260213", "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": "396490496", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WITH THE SYSTEM WAS IDENTIFIED DURING THE PROCEDURE WHEN STAFF REPORTED THAT THE INSTRUMENT RELEASE BUTTON ON ARM 2 WAS STUCK, PREVENTING REMOVAL OF THE INSTRUMENT. SYSTEM FUNCTIONALITY HAD BEEN CHECKED UPON POWERING ON AND CONFIRMED TO BE NORMAL, WITH NO ERRORS OBSERVED INITIALLY. FOR TROUBLESHOOTING, THE SITE CONTACTED TSE (TECHNICAL SUPPORT ENGINEER), NOT DVSTAT, AND FULL TROUBLESHOOTING WAS PERFORMED: STAFF WERE INSTRUCTED TO PRESS THE EMERGENCY RELEASE BUTTON, WHICH ENABLED REMOVAL OF THE INSTRUMENT, BUT THE PROCEDURE WAS ULTIMATELY CONVERTED TO LAPAROSCOPIC SURGERY. AN FSE (FIELD SERVICE ENGINEER) SUBSEQUENTLY VISITED, REPLACED ARM 2 ACCORDING TO WORK INSTRUCTIONS, REBOOTED THE SYSTEM, AND CONFIRMED NORMAL OPERATION THROUGH AN OPERATIONAL CHECK. THE PATIENT TOLERATED THE CONVERSION TO LAPAROSCOPIC SURGERY WITHOUT COMPLICATIONS. THE PATIENT SIDE MANIPULATOR (PSM) HAS BEEN RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "396490497", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395319592", "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 WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. HOWEVER, THE FSE REPLACED PSM #2 DUE TO THE CUSTOMER'S CLAIM THAT THE BUTTON ON THE ARM HAD GOTTEN STUCK. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE PSM HAS NOT BEEN COMPLETED." }, { "mdr_text_key": "395319593", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT RELEASE BUTTON ON PATIENT SIDE MANIPULATOR (PSM) #2 WAS STUCK AND NOT RESPONDING. THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY USING AN UNSPECIFIED HOSPITAL-OWNED TOOL, BUT THE PROBLEM PERSISTED. THE CUSTOMER UNDOCKED THE PSMS AND AN \"ACCESS PORT\" FROM AN INSTRUMENT ARM. THE CUSTOMER WAS ABLE TO SUCCESSFULLY REMOVE THE INSTRUMENT AFTER BEING INSTRUCTED TO PRESS AN EMERGENCY RELEASE BUTTON. HOWEVER, THE CUSTOMER ELECTED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY FOR AN UNSPECIFIED REASON. IT IS UNCLEAR IF THE PSM ISSUE CONTRIBUTED TO THE CUSTOMER'S DECISION TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY." }, { "mdr_text_key": "397813673", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED SYSTEM COMPONENT(S) TO RESOLVE THE REPORTED ISSUE. THE PATIENT SIDE MANIPULATOR (PSM) HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. DURING VISUAL INSPECTION, THE EMERGENCY INSTRUMENT RELEASE BUTTON WAS FOUND TO BE \"STICKY\" AND \"SLUGGISH\" WHEN PRESSED DOWN. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE PSM FUNCTIONED AS EXPECTED. THE EMERGENCY RELEASE BUTTON WAS TESTED NUMEROUS TIMES WITH STERILE ADAPTERS AND INSTRUMENTS INSTALLED HOWEVER NO ISSUES WERE IDENTIFIED. THE UNIT WAS THEN INSTALLED ONTO A SYSTEM WHERE IT PASSED ALL TESTING WITHIN SPECIFICATION. THE EMERGENCY RELEASE BUTTON ASSEMBLY WAS REMOVED FROM THE PSM AND DISASSEMBLED FOR FURTHER INVESTIGATION. FA WAS ABLE TO IDENTIFY USING A PIN GAUGE THAT THE EMERGENCY INSTRUMENT RELEASE BUSHING HOLE WHERE THE BUTTON SHAFT ENTERS THROUGH WAS OUT OF TOLERANCE." }, { "mdr_text_key": "397814502", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "03/13/2026;04/08/2026" } ] }