{ "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": "2955842-2022-10125", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20220127", "manufacturer_address_2": "", "pma_pmn_number": "K171426", "date_of_event": "20211230", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220127", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "72528", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220127", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE", "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": "470027-62", "catalog_number": "470027", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220127", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874112212", "udi_public": "(01)00886874112212", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/07/2022;12/30/2021", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "Y", "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": "20220127", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20211230", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13368985", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211230", "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": "289254537", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE THE ENDOSCOPE (SERIAL NUMBER (SN): (B)(4)) EXPERIENCED COMMUNICATION ISSUES WHEN INSTALLED. THE OPERATING ROOM STAFF RESEATED THE ENDOSCOPE WHEN THE ERRORS OCCURRED, BUT THE ISSUE PERSISTED. THE SITE POWER CYCLED THE SYSTEM, AND WHEN THE ENDOSCOPE WAS REINSTALLED THE ERRORS RETURNED. THE PATIENT BEGAN TO BLEED DURING THE TROUBLESHOOTING AND THE SITE CONVERTED TO OPEN RATHER THAN REPLACING THE ENDOSCOPE. THE PATIENT IS REPORTEDLY IN GOOD HEALTH AFTER THIS PROCEDURE. ON 19-JAN-2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ENDOSCOPE ISSUES OCCURRED AT THE END OF THE PROCEDURE WHEN THE SURGEON WAS REMOVING THE TUMOR. THE PATIENT'S SPLEEN WAS SCRAPED AND ABOUT 50CC'S OF BLOOD WAS LOST IN TOTAL DUE TO THIS EVENT. THE SURGEON SAID THE BLEEDING WAS RESOLVED BY PLACING PRESSURE ON THE TISSUE." }, { "mdr_text_key": "289254538", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DETERMINED TO BE RELATED TO THE CUSTOMER EXPERIENCED ENDOSCOPE ERRORS. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ENDOSCOPE FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS INVESTIGATION OR IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS FOR THE PROCEDURE DATE OF (B)(6) 2021 HAS BEEN PERFORMED BY AND THE FOLLOWING WAS OBSERVED: TWO ERROR 45310'S OCCURRED INDICATING THAT THE ENDOSCOPE VIDEO WAS NOT CONNECTING TO THE ENDOSCOPIC CONTROLLER AND REQUIRED THE ENDOSCOPE TO BE RESEATED. AN ERROR 45314 OCCURRED INDICATING THE ENDOSCOPE VIDEO WAS FROZEN AND HAD A POOR CONNECTION. ADDITIONALLY, THE ENDOSCOPE (SERIAL (B)(4)) WAS THE ONLY ENDOSCOPE USED DURING THIS PROCEDURE. THIS ENDOSCOPE WAS USED IN FIVE SUBSEQUENT PROCEDURES AND IS BEING RETURNED WITH A SEPARATE COMPLAINT MADE AGAINST IT FOR GIVING ERRORS MESSAGES AND NOT DETECTING ITS TEMPERATURE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT¿S SPLEEN WAS REPORTEDLY DAMAGED DURING A DA VINCI-ASSISTED PROCEDURE INVOLVING ENDOSCOPE VISION ISSUES. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN TO RESOLVE THE BLEEDING EVENT. THE ROOT CAUSE OF THE BLEEDING EVENT IS UNKNOWN." }, { "mdr_text_key": "329684939", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN \"ADVERSE EVENT AND PRODUCT PROBLEM\" RATHER THAN JUST AN \"ADVERSE EVENT\" AS PREVIOUSLY REPORTED DUE TO THE REPORT OF THE SITE CONVERTED TO OPEN TO CONTROL BLEEDING DURING TROUBLESHOOTING WITH THE ENDOSCOPE, WHICH COULD POTENTIALLY BE RELATED TO A PRODUCT PROBLEM. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELDS: B1. B1 UPDATED FROM \"ADVERSE EVENT\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\"." }, { "mdr_text_key": "328235931", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "328235932", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11, D14: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED EVENT BUT DID NOT REPLICATE IT DURING IN-HOUSE TESTING. ERRORS WERE OBSERVED IN THE ENDOSCOPE LOGS. THE IMAGE IN BOTH CAMERAS WAS GOOD. THERE WERE NO ERRORS AT THE QAP SYSTEM. AEA FRICTION AT THE BINDING WAS DISCOVERED. DESICCANT BALLS WERE FOUND DISLODGED." } ], "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": "03/08/2022;06/07/2022" } ] }