{ "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": "2955842-2023-17584", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230808", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230710", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230808", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220216", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2335763", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230808", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230713", "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": [ "Positioning Failure", "Positioning Failure" ], "reporter_state_code": "OK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/10/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "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": "20230808", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "110 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "American Indian Or Alaskan Native", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230710", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17483494", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230710", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "338715460", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE PROCEDURE BEGAN AS A SINGLE PORT ROBOTIC CASE, AND THE SURGICAL STAFF HAD TO MOVE THE PATIENT TO A MULTIPORT ROBOTIC ROOM TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY." }, { "mdr_text_key": "338715481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "321054293", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY, THE CUSTOMER WAS NOT ABLE TO INSERT THE CAMERA INTO THE PATIENT. THEY COULD ADVANCE OTHER INSTRUMENT DRIVES ALL THE WAY DOWN BUT NOT THE CAMERA DRIVE. THE CUSTOMER CHANGED OUT THE ENDOSCOPE AND RESEATED THE DRAPE WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ADVISED TO PRESS E-STOP, RECOVER, AND POWER CYCLE, HOWEVER, THERE WAS NO CHANGE. THE CUSTOMER CONFIRMED THE OTHER ARMS WOULD GO IN WITH NO CHANGE. THE CUSTOMER THEN STATED THE ENDOSCOPE INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) WAS WORKING. THE CUSTOMER WAS ABLE TO PUSH THE INSTRUMENT DRIVE DOWN WHEN THE ARM WAS IN AN UPRIGHT POSITION BUT AS SOON AS THEY LOWERED IT BACK DOWN, THE ISSUE RETURNED. THE CUSTOMER WAS GOING TO INSTALL THE CAMERA AND ADVANCE IT AND THEN MOVE THE ARM DOWN TO A USABLE ANGLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "321054294", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BEING UNABLE TO INSERT THE CAMERA INTO THE PATIENT DUE TO THE SET-UP JOINT (SUJ) OF THE PATIENT SIDE MANIPULATOR (PSM), AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED PSM-4 TO RESOLVE THE ISSUE AFTER IDENTIFYING A BROKEN BELT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM A FAILURE ANALYSIS. THE PSM WAS ANALYZED AND FOUND TO HAVE THE DISTAL INSERTION BELT BROKEN. THE FA WAS UNABLE TO TEST THE CAMERA INSERTION DUE TO THE BROKEN BELT. THE FA WAS UNABLE TO COMPLETE SYSTEM TESTING DUE TO THE BROKEN BELT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/07/2023" } ] }