{ "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": "2955842-2023-16988", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230712", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230616", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230712", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190510", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "313228", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230712", "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": "380601-34", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230627", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Difficult to Insert", "Difficult to Insert" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20230712", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230616", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17313308", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230616", "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": "318934165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETERAL REIMPLANTATION SURGICAL PROCEDURE THAT PATIENT SIDE MANIPULATOR (PSM) 3 WAS NOT ACCEPTING THE DRAPE. THE SITE TRIED RESEATING THE DRAPE MULTIPLE TIMES. A 30900 ERROR ALSO OCCURRED. THE SITE CHECKED TO ENSURE THAT THE DRAPE WAS EVEN, AND NO PART OF THE DRAPE WAS UNDERNEATH THE STERILE ADAPTOR. THE CUSTOMER RE-DRAPED THE SYSTEM, WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER EMERGENCY POWER OFF (EPO), AND POWER CYCLE THE SYSTEM, WITH NO CHANGE. THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE FROM THE SINGLE-PORT SYSTEM TO THEIR XI SYSTEM. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE NO ERRORS OBSERVED BY THE CUSTOMER. THE DELAY WAS ROUGHLY ONE HOUR." }, { "mdr_text_key": "318934166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT PSM 3 WAS NOT ACCEPTING DRAPES, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE FSE VERIFIED THAT PATIENT SIDE MANIPULATOR (PSM) 3 WAS HAVING A CONNECTION ISSUE, HOWEVER THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WAS SURE THAT THE REPORTED DRAPE CONNECTION ISSUE OCCURRED ON PSM 2. THE FSE USED HOSPITAL TRAINING ADAPTORS AND INSTRUMENTS ON THE SYSTEM AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. AS A PRECAUTION THE FSE REPLACED PSMS 2 AND 3. THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI DID RECEIVE BOTH PSM TO PERFORM FAILURE ANALYSIS (FA). ON (B)(4), FA WAS ABLE TO CONFIRM/REPRODUCE THE CUSTOMER REPORTED COMPLAINT. IN LOGS, (B)(4) ERRORS WERE SEEN POINTING TO A RETENTION PLATE PIN STUCK. UPON INSPECTING THE SPRING PINS, THE RETENTION PLATE RIGHT PIN WAS FOUND VERY SLUGGISH WHEN PUSHING THE PIN. THE PSM PASSED ALL FA SYSTEM AND PSC FIXTURE TEST PLATFORM (PFTP) TESTING. AS A FIX, THE SPRING PINS WILL BE REPLACED. THE STERILE ADAPTER (SA) MOUNT WILL ALSO BE REPLACED TO ACCOMMODATE THE REPAIR. ON (B)(4), FA WAS NOT ABLE TO CONFIRM/REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THIS UNIT WAS ONE OF TWO PSM'S THAT WERE RETURNED FOR THIS SAME ISSUE. THE FSE FOUND THE ERROR TO BE ON THE OTHER RETURNED PSM, WHICH WAS REPLICATED DURING FAILURE ANALYSIS. HOWEVER, THE CUSTOMER CLAIMED THE ISSUE TO BE ON REPORTING ON THIS PSM, SO THEREFORE BOTH PSM'S WERE RETURNED. THIS UNIT PASSED ALL FA SYSTEM AND PFTP TESTING WITH NO ISSUE RELATED TO STERILE ADAPTER ENGAGEMENT. FA WILL BE CONSIDERING THIS PSM AS A WRONG PART SENT BACK. NO PARTS WILL BE REPLACED IN RELATION THE REPORTED PROBLEM." } ], "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": "" } ] }