{ "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": "2955842-2022-16199", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20221229", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20221201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "408", "date_added": "20221230", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211117", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2613316", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221229", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE PLUS", "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": "470057-08", "catalog_number": "470057", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20221213", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Unintended System Motion" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20221229", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hematoma" ] } ], "distributor_city": "", "date_report": "20221202", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16075818", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221202", "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": "306408272", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS RECEIVED THE ENDOSCOPE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER RELATED COMPLAINT. THE ENDOSCOPE WAS FOUND TO HAVE THE FOLLOWING: AEA DAMAGED OR FRICTION ISSUE, HOUSING DISCOLORATION, AND A TRANSMITTANCE TEST FAILURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS NOT PERFORMED FOR THIS PROCEDURE: THE SYSTEM LOGS ARE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN UNSPECIFIED DA VINCI-ASSISTED UNSPECIFIED UROLOGIC PROCEDURE, NON-INTUITIVE MOTION OF INSTRUMENTS WAS EXPERIENCED AFTER THE SURGEON GAVE THE COMMAND TO TURN THE ENDOSCOPE 180 DEGREES. IT WAS ALLEGED THAT THE INSTRUMENTS STARTED WORKING IN THE OPPOSITE DIRECTION. AFTER THE EVENT OCCURRED, A HEMATOMA FORMED ON THE KIDNEY. THE SURGEON MADE THE CLINICAL DECISION TO ABORT THE PROCEDURE AFTER DETERMINING THAT PROCEEDING WAS TOO RISKY DUE TO THE HEMATOMA. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "306408273", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED UROLOGIC PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOTION OF INSTRUMENTS INVOLVING THE USE OF A 30-DEGREE ENDOSCOPE. THE ISSUE OCCURRED WHEN THE SURGEON GAVE THE COMMAND TO TURN THE ENDOSCOPE 180 DEGREES, WHICH CAUSED THE INSTRUMENTS TO START WORKING IN THE OPPOSITE, OR MIRRORED, DIRECTION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE LIVE LOGS AND DID NOT NOTE ANY ASSOCIATED ERRORS. THE SYSTEM WAS RESTARTED, AND THE ENDOSCOPE WAS RESEATED. THERE WAS A PROCEDURAL DELAY DUE TO TROUBLESHOOTING. AFTER THE REVERSED MOTION OF THE INSTRUMENTS, A HEMATOMA FORMED ON THE KIDNEY. THE SURGEON MADE THE CLINICAL DECISION TO ABORT THE PROCEDURE AFTER DETERMINING THAT PROCEEDING WAS TOO RISKY DUE TO THE HEMATOMA. PER THE SITE, THE PROCEDURE WILL BE RESCHEDULED TO ANOTHER DAY AFTER THE HEMATOMA HAS DISSIPATED." } ], "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": "" } ] }