{ "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": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DRIVE", "manufacturer_contact_pcity": "62825447", "event_type": "Injury", "report_number": "3014447948-2024-00002", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240229", "manufacturer_address_2": "", "pma_pmn_number": "K213334", "date_of_event": "20240129", "reprocessed_and_reused_flag": "Y", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "6282544750", "noe_summarized": "1", "manufacturer_contact_l_name": "KAUR", "source_type": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "628", "date_added": "20240301", "manufacturer_contact_f_name": "HARMINDER", "device_date_of_manufacturer": "20231201", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1910445", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240229", "brand_name": "MONARCH PLATFORM, UROLOGY", "generic_name": "URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID", "manufacturer_d_name": "AURIS HEALTH, INC.", "manufacturer_d_address_1": "150 SHORELINE DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "REDWOOD CITY", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94065", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94065", "device_operator": "HEALTH PROFESSIONAL", "model_number": "MUR-000011", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FGB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Ureteroscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Improper or Incorrect Procedure or Method", "Insufficient Device Problem Information", "Improper or Incorrect Procedure or Method", "Insufficient Device Problem Information" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/16/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6282", "patient": [ { "patient_sequence_number": "1", "date_received": "20240229", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions", "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20240318", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "18813288", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240216", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94065", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "336615902", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING THE CLINICAL STUDY TRIAL CASE UNEXPECTED VIDEO QUALITY WAS OBSERVED ON URETEROSCOPE. THE UNEXPECTED VIDEO QUALITY CONSISTED OF BLURRINESS ON THE SYSTEM DISPLAY. THE BLURRY VISION WAS ONLY OBSERVED DURING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE OF THE PRODUCT WORKFLOW, NAMELY DURING URETEROSCOPE DRIVING WITH THE LASER DRIVER COMPONENT CONNECTED. UPON REPLACEMENT OF THE URETEROSCOPE, NO FURTHER VIDEO ISSUES WERE OBSERVED AND THE USER COMPLETED THE CASE. UNDER PRELIMINARY INVESTIGATION THE URETEROSCOPE WAS EXAMINED UNDER MAGNIFICATION, AT WHICH TIME IT WAS DISCOVERED THAT THE TOP LAYER OF THE CAMERA LENS WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES." }, { "mdr_text_key": "336615903", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY AURIS HEALTH, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, AURIS HEALTH, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "341499995", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IN INVESTIGATION OF RETURNED PRODUCT, IT WAS DISCOVERED THAT AT LEAST ONE LAYER OF THE CAMERA LENS STACK HAD DELAMINATED, LEAVING A VACANT RECTANGULAR HOLE IN THE URETEROSCOPE TIP. REVIEW OF CASE VIDEO IDENTIFIED THERE WAS A USER ERROR WHICH VIOLATED OUR IFUS. THE USER WAS ACTUATING THE LASER FIBER AND COMMANDED LASER FIBER RETRACTING. THE LASER FIBER WAS NOT VISIBLE IN THE CAMERA IMAGE AS IT WAS FIRED. OUR IFUS STATE THAT THE LASER FIBER MUST ONLY BE ACTUATED WHEN THE FIBER TAKES UP ~1/3 OF THE CAMERA FIELD OF VIEW (FOV). THE IMAGE BLURRINESS BEGAN IMMEDIATELY AFTER THIS EVENT. IT WAS IDENTIFIED THAT THIS DELAMINATION OCCURRED DUE TO THIS ERRONEOUS USE OF THE LASER." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "628", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/18/2024" } ] }