{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-03845", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20130930", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20130823", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130930", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "491839", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130930", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20130911", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Loss of Power" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20130930", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20130828", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3375033", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130911", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3930713", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S NEPHRECTOMY PROCEDURE, THE INITIAL REPORTER, A ROBOTICS COORDINATOR, INDICATED THAT THE ILLUMINATOR LOST POWER AND WENT OUT ON THE VISION SIDE CART (VSC). AFTER THE ILLUMINATOR LOST POWER, A SURGICAL STAFF MEMBER DROPPED A NEEDLE USED FOR SUTURING WHILE ATTEMPTING TO REMOVE THE NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT. THROUGH TROUBLESHOOTING, THE ROBOTICS COORDINATOR REBOOTED THE VSC AND ILLUMINATOR. THE ROBOTICS COORDINATOR ALSO REPLACED THE POWER CORD AND TRIED A DIFFERENT ELECTRICAL OUTLET. HOWEVER, THE VISION ISSUE PERSISTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AFTER THE ROBOTICS COORDINATOR IMPLEMENTED AN EXTERNAL LIGHT SOURCE. AFTER COMPLETION OF THE SURGICAL PROCEDURE, AN X-RAY WAS PERFORMED TO ASSIST WITH SEARCHING FOR THE DROPPED NEEDLE. ON (B)(4) 2013, AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE SYSTEM BY REPLACING THE ILLUMINATOR." }, { "mdr_text_key": "11192521", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ILLUMINATOR HAS BEEN RETURNED FOR EVALUATION. HOWEVER, AT THIS TIME THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED POST-FAILURE ANALYSIS EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, ISI CONTACTED THE ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE ROBOTICS COORDINATOR INDICATED THAT DURING RESECTION OF THE PATIENT'S KIDNEY, THE ILLUMINATOR LOST POWER AND ALL VISION WAS LOST. THE ROBOTICS COORDINATOR INDICATED THAT THE SURGEON COULD NOT VIEW ANYTHING IN THE SURGICAL FIELD SINCE THE LIGHT SOURCE WAS NO LONGER AVAILABLE. WHILE THE ROBOTICS COORDINATOR WAS TROUBLESHOOTING, A SURGICAL STAFF MEMBER ATTEMPTED TO REMOVE A NEEDLE USED FOR SUTURING THROUGH A LAPAROSCOPIC ASSIST PORT. ACCORDING TO THE ROBOTICS COORDINATOR, THE NEEDLE WAS DROPPED BUT NO ATTEMPT WAS MADE AT THAT TIME TO SEARCH FOR THE NEEDLE SINCE THE SURGICAL FIELD COULD NOT BE VIEWED. AFTER THE ROBOTICS COORDINATOR WAS ABLE TO UTILIZE AN EXTERNAL LIGHT SOURCE, THE SURGICAL STAFF CONTINUED WITH THE DA VINCI SURGICAL PROCEDURE. AFTER COMPLETION OF THE DA VINCI PROCEDURE, THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO FIND THE DROPPED NEEDLE. RADIOLOGY WAS THEN CONTACTED AND AN X-RAY WAS PERFORMED TO HELP LOOK FOR THE NEEDLE THAT HAD BEEN DROPPED. AFTER THE X-RAY WAS PERFORMED AND THE NEEDLE WAS FOUND, AN INCISION WAS MADE BY THE SURGEON AND THE NEEDLE WAS RETRIEVED LAPAROSCOPICALLY. THE ROBOTICS COORDINATOR INDICATED THAT 45-55 MINUTES WERE ADDED TO THE DURATION OF THE SURGICAL PROCEDURE BECAUSE OF THE SEARCH AND RETRIEVAL OF THE NEEDLE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER THE ILLUMINATOR LOST POWER, A NEEDLE WAS DROPPED IN THE PATIENT AND AN X-RAY WAS PERFORMED AS AN ATTEMPT TO SEARCH FOR THE NEEDLE. AFTER THE NEEDLE WAS FOUND VIA THE X-RAY, THE SURGEON MADE AN ADDITIONAL INCISION TO RETRIEVE THE NEEDLE LAPAROSCOPICALLY." }, { "mdr_text_key": "11713808", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ILLUMINATOR WAS RETURNED AND EVALUATED. THE REPORTED CUSTOMER FAILURE MODE OF THE LIGHT SOURCE NOT POWERING UP WAS CONFIRMED. THE POWER SUPPLY AND CONTROL BOARD FAILED TESTING. AN UNSTABLE LAMP CURRENT WAS OBSERVED. IN ADDITION, THE ILLUMINATOR COVER WAS FOUND TO BE SCRATCHED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/05/2014" } ] }